<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/NCT02988713</url>
  </required_header>
  <id_info>
    <org_study_id>91153461</org_study_id>
    <nct_id>NCT02988713</nct_id>
  </id_info>
  <brief_title>Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial</brief_title>
  <official_title>Study to Characterize the Effects of Programming Spinal Cord Stimulation (SCS) in Patients Undergoing a Boston Scientific (BSC) SCS Temporary Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, non-randomized, exploratory, single-arm study&#xD;
      characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing&#xD;
      a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2016</start_date>
  <completion_date type="Actual">December 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2020</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Comfort</measure>
    <time_frame>An estimated average of 7 days post temporary trial procedure</time_frame>
    <description>Number of participants reporting comfort level of stimulation sensation as &quot;Very Comfortable&quot; or &quot;Slightly Comfortable&quot;</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Spinal cord stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Programming</intervention_name>
    <description>Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial</description>
    <arm_group_label>Spinal cord stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC&#xD;
             neurostimulation system, per local directions for use (DFU).&#xD;
&#xD;
          -  Subject signed a valid, Institutional Review Board (IRB)-approved informed consent&#xD;
             form.&#xD;
&#xD;
          -  Subject is 18 years of age or older when written informed consent is obtained.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Subject meets any contraindication in BSC neurostimulation system local directions for&#xD;
             use (DFU).&#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>Roshini Jain, M.S.</last_name>
    <role>Study Director</role>
    <affiliation>Boston Scientific Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pacific Pain Management, Inc.</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PCPMG Clinical Research Unit, LLC</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>December 1, 2021</results_first_submitted>
  <results_first_submitted_qc>March 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2022</results_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stimulation</keyword>
  <keyword>chronic pain</keyword>
  <keyword>back pain</keyword>
  <keyword>leg pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>June 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02988713/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>35 subjects were enrolled in and started the study. 2 were withdrawn prior to the Programming Visit. 33 started the Programming Visit and 32 completed the study. Statistically relevant conclusions cannot be made from this small sample size.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Spinal Cord Stimulation</title>
          <description>Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial&#xD;
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject's failure to meet study inclusion or exclusion criteria after enrollment</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Spinal Cord Stimulation</title>
          <description>Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial&#xD;
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </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="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Work Status</title>
          <population>Analysis population n = 35. Measures are not mutually exclusive: one subject reported Work Status of both &quot;Unemployed&quot; and &quot;Retired&quot;. Additionally, one subject did not report work status.</population>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Disability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Employed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retired</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Student</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unemployed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Comfort</title>
        <description>Number of participants reporting comfort level of stimulation sensation as &quot;Very Comfortable&quot; or &quot;Slightly Comfortable&quot;</description>
        <time_frame>An estimated average of 7 days post temporary trial procedure</time_frame>
        <population>32 subjects completing the Programming Visit</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulation</title>
            <description>Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial&#xD;
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Comfort</title>
          <description>Number of participants reporting comfort level of stimulation sensation as &quot;Very Comfortable&quot; or &quot;Slightly Comfortable&quot;</description>
          <population>32 subjects completing the Programming Visit</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="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events reported from enrollment to end of study (up to 15 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Spinal Cord Stimulation</title>
          <description>Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial&#xD;
Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial</description>
        </group>
      </group_list>
      <serious_events>
        <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="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="35"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Clinical Sciences and Scientific Communication</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@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/NCT02988713
org study id: 91153461
nct id: NCT02988713
lead sponsor: 
This is a prospective, multi-center, non-randomized, exploratory, single-arm study
      characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing
      a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Patient Comfort
time frame: An estimated average of 7 days post temporary trial procedure
description: Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
arm group label: Spinal cord stimulation
arm group type: Experimental
description: Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
intervention type: Device
intervention name: Programming
description: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
arm group label: Spinal cord stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roshini Jain, M.S.
role: Study Director
affiliation: Boston Scientific Corporation
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 