<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/NCT03251937</url>
  </required_header>
  <id_info>
    <org_study_id>A4064</org_study_id>
    <nct_id>NCT03251937</nct_id>
  </id_info>
  <brief_title>Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System</brief_title>
  <acronym>VERITAS</acronym>
  <official_title>VERITAS - A Study to Demonstrate the Value of Multiple Modalities Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate the value of multiple modalities and sustained clinically significant pain&#xD;
      relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter&#xD;
      Spinal Cord Stimulator (SCS) System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2018</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 9, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline</measure>
    <time_frame>3 months post activation</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Spinal Cord Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spectra WaveWriter SCS System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spectra WaveWriter SCS System</intervention_name>
    <description>Multiple modalities of stimulation therapy</description>
    <arm_group_label>Spinal Cord Stimulation</arm_group_label>
    <other_name>Spectra WaveWriter Spinal Cord Stimulation System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Chronic pain of the trunk and/or limbs&#xD;
&#xD;
          -  22 years of age or older at time of enrollment&#xD;
&#xD;
          -  Willing and able to comply with all protocol-required procedures and&#xD;
             assessments/evaluations provided in English&#xD;
&#xD;
          -  Willing and capable of giving informed consent&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Any pain-related diagnosis or medical/psychological condition that, in the clinician's&#xD;
             best judgment, might confound reporting of study outcomes&#xD;
&#xD;
          -  Significant cognitive impairment that, in the opinion of the Investigator, would&#xD;
             reasonably be expected to impair the study candidate's ability to participate in the&#xD;
             study&#xD;
&#xD;
          -  Current systemic infection, or local infection in close proximity to the anticipated&#xD;
             surgical field&#xD;
&#xD;
          -  Breast-feeding, pregnant or planning to get pregnant during the course of the study or&#xD;
             not using adequate contraception&#xD;
&#xD;
          -  Previous spinal cord stimulation trial or is already implanted with an active&#xD;
             implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)&#xD;
&#xD;
          -  Participating, or intends to participate, in another clinical trial that may influence&#xD;
             the data that will be collected for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roshini Jain</last_name>
    <role>Study Director</role>
    <affiliation>Boston Scientific Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neurovations</name>
      <address>
        <city>Napa</city>
        <state>California</state>
        <zip>94558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louis J. Raso, MD, PA</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Pain Clinic</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forest Health Medical Center</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Research Institute</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical Research, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Reserve Spine and Pain Institute</name>
      <address>
        <city>Kent</city>
        <state>Ohio</state>
        <zip>44240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Chester Hospital, LLC</name>
      <address>
        <city>West Chester</city>
        <state>Ohio</state>
        <zip>45069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Sports and Spine, LLC</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spine Team Texas</name>
      <address>
        <city>Rockwall</city>
        <state>Texas</state>
        <zip>75032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Neuroscience Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Pain Management Appleton</name>
      <address>
        <city>Appleton</city>
        <state>Wisconsin</state>
        <zip>54913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <results_first_submitted>January 21, 2020</results_first_submitted>
  <results_first_submitted_qc>March 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2020</results_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Pain</keyword>
  <keyword>Back Pain</keyword>
  <keyword>Leg Pain</keyword>
  <keyword>Pain</keyword>
  <keyword>Stimulation</keyword>
  <keyword>Spinal Cord Stimulator</keyword>
  <keyword>Implantable Pulse Generator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <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>May 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03251937/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and proceed in the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Spinal Cord Stimulation</title>
          <description>Spectra WaveWriter SCS System&#xD;
Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Spinal Cord Stimulation</title>
          <description>Spectra WaveWriter SCS System&#xD;
Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.2" spread="12"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline</title>
        <time_frame>3 months post activation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulation</title>
            <description>Spectra WaveWriter SCS System&#xD;
Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study</time_frame>
      <desc>Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study</desc>
      <group_list>
        <group group_id="E1">
          <title>Spinal Cord Stimulation</title>
          <description>Spectra WaveWriter SCS System&#xD;
Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>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="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Sinus Node Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="97"/>
              </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 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>
    <point_of_contact>
      <name_or_title>Director of Clinical Sciences</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>661 949 4350</phone>
      <email>roshini.jain@bsci.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/NCT03251937
org study id: A4064
nct id: NCT03251937
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To demonstrate the value of multiple modalities and sustained clinically significant pain
      relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter
      Spinal Cord Stimulator (SCS) System.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
time frame: 3 months post activation
arm group label: Spinal Cord Stimulation
arm group type: Experimental
description: Spectra WaveWriter SCS System
intervention type: Device
intervention name: Spectra WaveWriter SCS System
description: Multiple modalities of stimulation therapy
arm group label: Spinal Cord Stimulation
other name: Spectra WaveWriter Spinal Cord Stimulation System
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Roshini Jain
role: Study Director
affiliation: Boston Scientific Corporation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Chronic Pain
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 