<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03277378</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10116</org_study_id>
    <nct_id>NCT03277378</nct_id>
  </id_info>
  <brief_title>Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial</brief_title>
  <acronym>DELIVERY</acronym>
  <official_title>Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multi-center, randomized, single blind study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical investigation compares success rates for anatomically placed leads to&#xD;
      conventional, targeted lead placement for BurstDR™ during the trial evaluation period with&#xD;
      the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and&#xD;
      randomized in a 1:1 ratio as follows:&#xD;
&#xD;
      Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial&#xD;
      trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™&#xD;
      stimulation during an initial trial evaluation period&#xD;
&#xD;
      If the subject qualifies for permanent system implant according to pre-defined criteria after&#xD;
      the initial trial evaluation period, the subject will exit the clinical investigation and&#xD;
      continue their treatment per the physician's standard of care. Subjects who do not qualify&#xD;
      for permanent system implant according to pre-defined criteria after the initial trial&#xD;
      evaluation period may participate in an extended trial evaluation period, per physician&#xD;
      discretion, during which they will be programmed with tonic stimulation. Subjects continuing&#xD;
      to an extended trial evaluation period will be followed through the completion of the&#xD;
      extended trial period. At the end of the extended trial evaluation period, subjects will exit&#xD;
      the clinical investigation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">October 12, 2018</completion_date>
  <primary_completion_date type="Actual">August 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period.&#xD;
Qualification for permanent system implant was defined by a composite where all the following conditions were met:&#xD;
≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation&#xD;
Trial evaluation period lasted for a minimum of 3 days&#xD;
Physician recommends subject for permanent system implant&#xD;
Subject reports a willingness to pursue a permanent system implant&#xD;
Subjects did not qualify for permanent system implant if they met both of the following:&#xD;
&lt; 50% PRP (patient reported pain relief) at the end of the trial evaluation&#xD;
Trial evaluation period lasted for a minimum of 5 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With One Trial Lead Implanted (US)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Programming Time Needed for Each Randomized Group</measure>
    <time_frame>Trial system implant</time_frame>
    <description>The programming time observed for both randomized groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period</measure>
    <time_frame>From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation</time_frame>
    <description>Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as &quot; wash-in period&quot;)</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Serious Adverse Device Effects (SADE) Based on Randomization</measure>
    <time_frame>From pre-implant to exit of the study, approximately 3 to 14 days</time_frame>
    <description>Rate of serious adverse device effects based on each randomized group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response</description>
  </other_outcome>
  <other_outcome>
    <measure>Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type</measure>
    <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
    <description>The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinician Affinity for Lead Placement Technique at the End of Trial Procedure</measure>
    <time_frame>Trial system implant</time_frame>
    <description>Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.</description>
  </other_outcome>
  <other_outcome>
    <measure>Permanent System Qualification Rate at the End of Extended Trial Period</measure>
    <time_frame>From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation</time_frame>
    <description>The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Chronic, Intractable Pain of the Trunk and/or Lower Limbs</condition>
  <arm_group>
    <arm_group_label>Group 1 (AB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (TB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lead placement followed by BurstDR stimulation</intervention_name>
    <description>lead placement followed by BurstDR stimulation</description>
    <arm_group_label>Group 1 (AB)</arm_group_label>
    <arm_group_label>Group 2 (TB)</arm_group_label>
    <other_name>Spinal Cord Stimulation non-surgical Leads</other_name>
    <other_name>Spinal Cord Stimulation Clinician Programmer</other_name>
    <other_name>Spinal Cord Stimulation Patient Controller</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved&#xD;
             labeling.&#xD;
&#xD;
          2. Patient's pain profile indicates appropriate lead placement would be at one or more&#xD;
             levels from T7 to T10, to achieve pain coverage.&#xD;
&#xD;
          3. Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours&#xD;
             for 'average overall pain'specific to the area(s) of chronic pain that will be treated&#xD;
             with spinal cord stimulation.&#xD;
&#xD;
          4. Patient is considered by the Study Investigator as a candidate for implantation of a&#xD;
             spinal cord stimulator system according to the system Instructions for Use.&#xD;
&#xD;
          5. Patient is &gt;18 years of age at the time of enrollment.&#xD;
&#xD;
          6. Patient is willing to adhere to the study requirements, including compliance with and&#xD;
             completion of all study visits.&#xD;
&#xD;
          7. Patient has signed and received a copy of the Ethical Committee/Independent Review&#xD;
             Board approved informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient currently has a spinal cord stimulation system implanted.&#xD;
&#xD;
          2. Patient has previously failed a spinal cord stimulation therapy (either trial system&#xD;
             evaluation or permanent system implant).&#xD;
&#xD;
          3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris,&#xD;
             or Chronic Migraine.&#xD;
&#xD;
          4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one&#xD;
             procedure)&#xD;
&#xD;
          5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robyn Capobianco, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jason Edward Pope, MD</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Spine Institute</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Pain Institute</name>
      <address>
        <city>Merritt Island</city>
        <state>Florida</state>
        <zip>32953</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Pain Institute Winter Park</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Pain Care</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Advanced Pain Specialists</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spinal Diagnostics</name>
      <address>
        <city>Tualatin</city>
        <state>Oregon</state>
        <zip>97062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Spine Care</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frankston Pain Management</name>
      <address>
        <city>Frankston</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Private Hospital</name>
      <address>
        <city>Saint Leonards</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Elisabethinen GmbH</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital Wien</name>
      <address>
        <city>Vienna</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Kliniken Duisburg Gm.bH</name>
      <address>
        <city>Duisburg</city>
        <zip>47055</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Einrichtungen der Universität Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie</name>
      <address>
        <city>Gera</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg Sud</name>
      <address>
        <city>Nürnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Salvatore Maugeri</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alrijne Ziekenhuis</name>
      <address>
        <city>Leiderdorp</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stichting Rijnstate Ziekenhuis - Velp</name>
      <address>
        <city>Velp</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>October 9, 2019</results_first_submitted>
  <results_first_submitted_qc>December 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 5, 2021</results_first_posted>
  <last_update_submitted>December 9, 2020</last_update_submitted>
  <last_update_submitted_qc>December 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Intractable</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03277378/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The subject enrollment for the DELIVERY study began on 22 September 2017, at 23 clinical sites in the United States, Europe, and Australia. A total of 270 subjects were randomized into the two treatment groups (Anatomic Lead Placement and Targeted lead placement).</recruitment_details>
      <pre_assignment_details>A total of 288 subjects were screened, of which 18 subjects were withdrawn before randomization due to unmet inclusion/exclusion criteria (n=6), withdrawal of the consent (n=11) and subject was on the clinic's wait list to receive an implant only after the study closed (n=1). The last follow-up visit occurred on 27 August 2018.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1 (AB)</title>
          <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
        </group>
        <group group_id="P2">
          <title>Group 2 (TB)</title>
          <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="135"/>
                <participants group_id="P2" count="135"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Lead Implant</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Initial Trial</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Qualified for Permanent Implant</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Not Qualified for Permanent Implant</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Extended Trial With Tonic Stim</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Exit Study</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline characteristics for all subjects randomized to anatomic or targeted lead placement were measured.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1 (AB)</title>
          <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
        </group>
        <group group_id="B2">
          <title>Group 2 (TB)</title>
          <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="135"/>
            <count group_id="B2" value="135"/>
            <count group_id="B3" value="270"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.8" spread="13.2"/>
                    <measurement group_id="B2" value="63.9" spread="13.8"/>
                    <measurement group_id="B3" value="62.8" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Austria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of having chronic pain</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="135"/>
                    <count group_id="B2" value="135"/>
                    <count group_id="B3" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.23" spread="11.83"/>
                    <measurement group_id="B2" value="10.69" spread="11.11"/>
                    <measurement group_id="B3" value="11.46" spread="11.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period</title>
        <description>The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period.&#xD;
Qualification for permanent system implant was defined by a composite where all the following conditions were met:&#xD;
≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation&#xD;
Trial evaluation period lasted for a minimum of 3 days&#xD;
Physician recommends subject for permanent system implant&#xD;
Subject reports a willingness to pursue a permanent system implant&#xD;
Subjects did not qualify for permanent system implant if they met both of the following:&#xD;
&lt; 50% PRP (patient reported pain relief) at the end of the trial evaluation&#xD;
Trial evaluation period lasted for a minimum of 5 days</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period</title>
          <description>The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period.&#xD;
Qualification for permanent system implant was defined by a composite where all the following conditions were met:&#xD;
≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation&#xD;
Trial evaluation period lasted for a minimum of 3 days&#xD;
Physician recommends subject for permanent system implant&#xD;
Subject reports a willingness to pursue a permanent system implant&#xD;
Subjects did not qualify for permanent system implant if they met both of the following:&#xD;
&lt; 50% PRP (patient reported pain relief) at the end of the trial evaluation&#xD;
Trial evaluation period lasted for a minimum of 5 days</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hypothesis was formally addressed as:&#xD;
H0: AB - TB ≤ -15% H1: AB - TB &gt; -15% where AB = permanent system qualification rate of Group 1 (AB) TB = permanent system qualification rate of Group 2 (TB)</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The hypothesis was tested at the 5% significance level.</non_inferiority_desc>
            <p_value>0.0003</p_value>
            <method>Farrington- Manning non-inferioirty test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study</title>
        <description>The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The analysis population included physicians who had performed both types of lead placement procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Physicians Who Prefer Anatomic Lead Placement</title>
            <description>Physicians who preferred anatomic placement of leads</description>
          </group>
          <group group_id="O2">
            <title>Physicians Who Prefer Targeted Placement of Leads</title>
            <description>Physicians who prefered targeted placement of leads</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study</title>
          <description>The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.</description>
          <population>The analysis population included physicians who had performed both types of lead placement procedures.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hypothesis was formally addressed as:&#xD;
H0: P ≤ 60% H1: P &gt; 60% where P= percentage of physician prefer anatomic placement over targeted placement.&#xD;
The analysis population included physicians who have performed both placement procedures. The hypothesis was tested at the 5% significance level.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2500</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With One Trial Lead Implanted (US)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had one trial lead implanted in sites in the United States.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With One Trial Lead Implanted (US)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had one trial lead implanted in sites in the United States.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.3" spread="4.7"/>
                    <measurement group_id="O2" value="52.9" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="9.4"/>
                    <measurement group_id="O2" value="30.3" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.48" spread="1.95"/>
                    <measurement group_id="O2" value="2.65" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had one trial lead implanted in sites outside the United States.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had one trial lead implanted in sites outside the United States.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="11.8"/>
                    <measurement group_id="O2" value="46.2" spread="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="6.8"/>
                    <measurement group_id="O2" value="21.5" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.22" spread="2.56"/>
                    <measurement group_id="O2" value="4.28" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had one trial lead implanted in sites worldwide</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had one trial lead implanted in sites worldwide</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.0" spread="13.6"/>
                    <measurement group_id="O2" value="49.8" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2" spread="15.2"/>
                    <measurement group_id="O2" value="26.2" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.59" spread="2.42"/>
                    <measurement group_id="O2" value="3.40" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had two trial leads implanted in sites in the United States.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had two trial leads implanted in sites in the United States.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="12.4"/>
                    <measurement group_id="O2" value="45" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="8.2"/>
                    <measurement group_id="O2" value="19.9" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="0.98"/>
                    <measurement group_id="O2" value="1.68" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had two trial leads implanted in sites outside the United States.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had two trial leads implanted in sites outside the United States.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" spread="10.4"/>
                    <measurement group_id="O2" value="57.3" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="11.7"/>
                    <measurement group_id="O2" value="30" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="1.56"/>
                    <measurement group_id="O2" value="3.24" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had two trial leads implanted in sites worldwide</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had two trial leads implanted in sites worldwide</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.4" spread="12.3"/>
                    <measurement group_id="O2" value="45.9" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" spread="8.5"/>
                    <measurement group_id="O2" value="20.6" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.65" spread="1.13"/>
                    <measurement group_id="O2" value="1.79" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had one permanent lead implanted in sites outside the United States.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had one permanent lead implanted in sites outside the United States.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.6" spread="16.2"/>
                    <measurement group_id="O2" value="68.6" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="9.4"/>
                    <measurement group_id="O2" value="22.6" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12" spread="0.88"/>
                    <measurement group_id="O2" value="2.83" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)</title>
        <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
        <time_frame>Trial system implant</time_frame>
        <population>Subjects include those who had two permanent leads implanted in sites outside the United States.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)</title>
          <description>Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.</description>
          <population>Subjects include those who had two permanent leads implanted in sites outside the United States.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" spread="4.6"/>
                    <measurement group_id="O2" value="92.3" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3" spread="5.1"/>
                    <measurement group_id="O2" value="27.3" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative fluoroscopy time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" spread="3.09"/>
                    <measurement group_id="O2" value="4.93" spread="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Programming Time Needed for Each Randomized Group</title>
        <description>The programming time observed for both randomized groups</description>
        <time_frame>Trial system implant</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Programming Time Needed for Each Randomized Group</title>
          <description>The programming time observed for both randomized groups</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="6.4"/>
                    <measurement group_id="O2" value="6" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period</title>
        <description>Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period</title>
          <description>Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.8"/>
                    <measurement group_id="O2" value="4.3" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period</title>
        <description>Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.</description>
        <time_frame>From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period</title>
          <description>Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="2.6"/>
                    <measurement group_id="O2" value="2.6" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant</title>
        <description>Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant</title>
          <description>Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 50% patient reported pain relief (PRP)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trial period lasted for a minimum of 3 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician recommendation for permanent implant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject's willingness for a permanent implant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.</title>
        <description>Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.</title>
          <description>Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)</title>
        <description>Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as &quot; wash-in period&quot;)</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)</title>
          <description>Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as &quot; wash-in period&quot;)</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.0"/>
                    <measurement group_id="O2" value="3.3" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rate of Serious Adverse Device Effects (SADE) Based on Randomization</title>
        <description>Rate of serious adverse device effects based on each randomized group.</description>
        <time_frame>From pre-implant to exit of the study, approximately 3 to 14 days</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Serious Adverse Device Effects (SADE) Based on Randomization</title>
          <description>Rate of serious adverse device effects based on each randomized group.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group</title>
        <description>A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group</title>
          <description>A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type</title>
        <description>The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response</description>
        <time_frame>From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects With Temporary Lead Implant</title>
            <description>Subjects who had temporary lead implant after randomization</description>
          </group>
          <group group_id="O2">
            <title>Subjects With Permanent Lead Implant</title>
            <description>Subjects who had Permanent lead implant after randomization</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type</title>
          <description>The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty</title>
        <description>Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.</description>
        <time_frame>Trial system implant</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty</title>
          <description>Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anesthesia related difficulty</title>
              <category_list>
                <category>
                  <title>No difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Little difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Could not place leads</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lead placement difficulty</title>
              <category_list>
                <category>
                  <title>No difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Little difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme difficulty</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Could not place leads</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinician Affinity for Lead Placement Technique at the End of Trial Procedure</title>
        <description>Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.</description>
        <time_frame>Trial system implant</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Clinician Affinity for Lead Placement Technique at the End of Trial Procedure</title>
          <description>Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>This was my usual practice</title>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Permanent System Qualification Rate at the End of Extended Trial Period</title>
        <description>The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.</description>
        <time_frame>From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (AB)</title>
            <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
          <group group_id="O2">
            <title>Group 2 (TB)</title>
            <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
          </group>
        </group_list>
        <measure>
          <title>Permanent System Qualification Rate at the End of Extended Trial Period</title>
          <description>The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 3 to 14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group 1 (AB)</title>
          <description>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
        </group>
        <group group_id="E2">
          <title>Group 2 (TB)</title>
          <description>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="135"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Spinal Cord Compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Stimulation in unwanted places</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="135"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Unpleasant sensations or Motor disturbances Including Involuntary Movement caused by high output</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Persistant pain lead site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="135"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Cerebrospinal fluid leakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>New leg pain on walking instead of original dysaesthetic sensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="135"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Lead Migration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="135"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was designed to collect data during the initial trial period only. Anatomic placement of leads may not provide adequate paresthesia coverage for patients wishing to periodically use a paresthesia-based stimulation design.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Robyn Capobianco, PhD</name_or_title>
      <organization>Abbott</organization>
      <phone>+1 512 286 4274</phone>
      <email>robyn.capobianco@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03277378
org study id: SJM-CIP-10116
nct id: NCT03277378
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Prospective, multi-center, randomized, single blind study
This clinical investigation compares success rates for anatomically placed leads to
      conventional, targeted lead placement for BurstDR™ during the trial evaluation period with
      the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and
      randomized in a 1:1 ratio as follows:

      Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial
      trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™
      stimulation during an initial trial evaluation period

      If the subject qualifies for permanent system implant according to pre-defined criteria after
      the initial trial evaluation period, the subject will exit the clinical investigation and
      continue their treatment per the physician's standard of care. Subjects who do not qualify
      for permanent system implant according to pre-defined criteria after the initial trial
      evaluation period may participate in an extended trial evaluation period, per physician
      discretion, during which they will be programmed with tonic stimulation. Subjects continuing
      to an extended trial evaluation period will be followed through the completion of the
      extended trial period. At the end of the extended trial evaluation period, subjects will exit
      the clinical investigation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period.
Qualification for permanent system implant was defined by a composite where all the following conditions were met:
≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation
Trial evaluation period lasted for a minimum of 3 days
Physician recommends subject for permanent system implant
Subject reports a willingness to pursue a permanent system implant
Subjects did not qualify for permanent system implant if they met both of the following:
< 50% PRP (patient reported pain relief) at the end of the trial evaluation
Trial evaluation period lasted for a minimum of 5 days
measure: Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.
measure: Procedural Characteristics of Subjects With One Trial Lead Implanted (US)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)
time frame: Trial system implant
description: Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
measure: Programming Time Needed for Each Randomized Group
time frame: Trial system implant
description: The programming time observed for both randomized groups
measure: Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
measure: Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period
time frame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
description: Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
measure: Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant
measure: Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.
measure: Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as " wash-in period")
measure: Rate of Serious Adverse Device Effects (SADE) Based on Randomization
time frame: From pre-implant to exit of the study, approximately 3 to 14 days
description: Rate of serious adverse device effects based on each randomized group.
measure: Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
measure: Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type
time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
description: The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
measure: Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty
time frame: Trial system implant
description: Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.
measure: Clinician Affinity for Lead Placement Technique at the End of Trial Procedure
time frame: Trial system implant
description: Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.
measure: Permanent System Qualification Rate at the End of Extended Trial Period
time frame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
description: The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.
arm group label: Group 1 (AB)
arm group type: Active Comparator
description: Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
arm group label: Group 2 (TB)
arm group type: Active Comparator
description: Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
intervention type: Device
intervention name: lead placement followed by BurstDR stimulation
description: lead placement followed by BurstDR stimulation
arm group label: Group 1 (AB)
arm group label: Group 2 (TB)
other name: Spinal Cord Stimulation non-surgical Leads
other name: Spinal Cord Stimulation Clinician Programmer
other name: Spinal Cord Stimulation Patient Controller
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robyn Capobianco, PhD
role: Study Director
affiliation: Abbott
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country: Australia
country: Austria
country: Germany
country: Italy
country: Netherlands
country: Sweden
country: United States
country: Canada
responsible party type: Sponsor
mesh term: Pain, Intractable
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was designed to collect data during the initial trial period only. Anatomic placement of leads may not provide adequate paresthesia coverage for patients wishing to periodically use a paresthesia-based stimulation design.
point of contact: 