<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/NCT02208999</url>
  </required_header>
  <id_info>
    <org_study_id>2011045</org_study_id>
    <secondary_id>913018</secondary_id>
    <nct_id>NCT02208999</nct_id>
  </id_info>
  <brief_title>Follow-up of Post-spinal Implantable Neurostimulator PRECISION®</brief_title>
  <acronym>PRECISION</acronym>
  <official_title>Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cemka-Eval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cemka-Eval</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessing the long-term efficacy, complications, revision rates and final explantation of the&#xD;
      device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Longitudinal study with a follow-up of 2 years in patients implanted with the Precision&#xD;
      neurostimulator.&#xD;
&#xD;
      This study will describe the characterisrics of the patients, of the implantation and will&#xD;
      assess the long-term efficacy, complications, revision rates and final explantation of the&#xD;
      device&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.</measure>
    <time_frame>From baseline until the end of the study at 24 months.</time_frame>
    <description>Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.</measure>
    <time_frame>From baseline until the end of the study at 24 months.</time_frame>
    <description>The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:&#xD;
pain at the present time&#xD;
usual pain over the past 8 days&#xD;
the most severe pain in the last 8 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' Opinion on the Evolution of Pain</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>- Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the Use of Other Pain Treatments</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Quality of Life (SF-12) - Physical Score</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical &quot;quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' Willingness to Restart the Treatment</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>Patients' willingness to restart the treatment at 12 months and at 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Anxiety and Depression Disorders</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Quality of Life (SF-12) - Mental Score</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental &quot;quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the Use of Level 3 Analgesics</measure>
    <time_frame>From baseline until the end of the study at 24 months</time_frame>
    <description>Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Chronic Refractory Neuropathic Pain</condition>
  <condition>Ischemic Peripheral Pain</condition>
  <arm_group>
    <arm_group_label>Neurostimulator Precision</arm_group_label>
    <description>Patients implanted or reimplanted with the neurostimulator Precision</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neurostimulator Precision</intervention_name>
    <description>All patients included must have been implanted with the neurostimulator Precision</description>
    <arm_group_label>Neurostimulator Precision</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All implanted patients (primary implementation and reimplantation) with the neurostimulator&#xD;
        PRECISION ®, during the inclusion period (1 year).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary&#xD;
             implantation or reimplantation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of patient&#xD;
&#xD;
          -  Patient whose long-term monitoring will not be possible&#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>Elisabeth Dr Mouton, MD</last_name>
    <role>Study Director</role>
    <affiliation>Boston Scientific Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospitals implanting the neurostimulator Precision</name>
      <address>
        <city>Multiple Locations</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <results_first_submitted>June 14, 2019</results_first_submitted>
  <results_first_submitted_qc>November 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2019</results_first_posted>
  <last_update_submitted>November 5, 2019</last_update_submitted>
  <last_update_submitted_qc>November 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>medullary neurostimulation</keyword>
  <keyword>pain</keyword>
  <keyword>Precision</keyword>
  <keyword>rechargeable</keyword>
  <keyword>implantable</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared; Only aggregated data will be communicated</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 7, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02208999/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02208999/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment between December 3, 2015 and October 21, 2015 in 7 French clinical centers</recruitment_details>
      <pre_assignment_details>No pre-assignment details</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Patients Implanted or Reimplanted With Precision</title>
          <description>All patients included must have been implanted with the neurostimulator Precision.107 patients were included. One of them was excluded because he was less than 18 years old. So 106 patients were analysed: 91 implanted patients (de novo implants) and 15 reimplanted patients (replacement implants)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Implanted Patients</title>
          <description>91 patients de novo implanted with the neurostimulator Precision.</description>
        </group>
        <group group_id="B2">
          <title>Reimplanted Patients</title>
          <description>15 patients had a replacement with the neurostimulator Precision.</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="91"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="106"/>
          </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="91"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.5" spread="11.0"/>
                    <measurement group_id="B2" value="51.7" spread="9.6"/>
                    <measurement group_id="B3" value="49.8" spread="10.8"/>
                  </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="91"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</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="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" 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>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="91"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Indication</title>
          <description>Type of pain for which the neurostimulator was implanted</description>
          <population>4 missing data</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="87"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Irreducible chronic neuropathic pain</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Peripheral ischaemic pain</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain location</title>
          <population>1 missing data</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="90"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Unilateral pain</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bilateral pain</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of pain before implant</title>
          <description>Mean age of pain (months)</description>
          <population>3 missing data</population>
          <units>Months</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="88"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.0" spread="68.5"/>
                    <measurement group_id="B2" value="118.8" spread="101.6"/>
                    <measurement group_id="B3" value="75.4" spread="75.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of pain surgery</title>
          <population>3 missing data</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="88"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>% of patients with a test phase before final implantation</title>
          <population>1 missing data</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="90"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage reduction in pain during the test phase</title>
          <population>95 patients had a phase test and 4 data was missing.</population>
          <units>percentage</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="83"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.2" spread="13.8"/>
                    <measurement group_id="B2" value="63.8" spread="11.9"/>
                    <measurement group_id="B3" value="68.8" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Electrode insertion pathways</title>
          <population>1 missing data</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="90"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Percutaneous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Laminectomy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Percutaneous + laminectomy</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_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.</title>
        <description>Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.</description>
        <time_frame>From baseline until the end of the study at 24 months.</time_frame>
        <population>Implanted patients (de novo implants)</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants)</title>
            <description>Primary outcome measure was estimated only in implanted patients (de novo implants)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.</title>
          <description>Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.</description>
          <population>Implanted patients (de novo implants)</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>% patients with pain reduction &gt;= 50% at &amp;1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" lower_limit="22.2" upper_limit="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% patients with pain reduction &gt;= 50% at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7" lower_limit="24.6" upper_limit="48.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale</title>
        <description>Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:&#xD;
pain at the present time&#xD;
usual pain over the past 8 days&#xD;
the most severe pain in the last 8 days</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Percentage of de novo patients with an improvement of at least 30% for pain at 12 and 24 months after inclusion</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Percentage of de novo patients with an improvement of at least 30% for pain at 12 months after inclusion</description>
          </group>
          <group group_id="O2">
            <title>Percentage of de Novo Patients at 24 Months</title>
            <description>Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale</title>
          <description>Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:&#xD;
pain at the present time&#xD;
usual pain over the past 8 days&#xD;
the most severe pain in the last 8 days</description>
          <population>Percentage of de novo patients with an improvement of at least 30% for pain at 12 and 24 months after inclusion</population>
          <units>% of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain at present time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.7" lower_limit="39.6" upper_limit="67.4"/>
                    <measurement group_id="O2" value="53.6" lower_limit="41.2" upper_limit="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual pain over the past 8 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5" lower_limit="40.6" upper_limit="68.0"/>
                    <measurement group_id="O2" value="51.4" lower_limit="39.2" upper_limit="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The most severe pain in the last 8 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3" lower_limit="32.6" upper_limit="60.4"/>
                    <measurement group_id="O2" value="40.6" lower_limit="28.9" upper_limit="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients' Opinion on the Evolution of Pain</title>
        <description>- Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Percentage of de novo patients for whom pain relief before the implantation was &quot;improved&quot; to &quot;very improved&quot; at 12 and 24 months</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Percentage of de novo patients for whom pain relief before the implantation was &quot;improved&quot; to &quot;very improved&quot; at 12 months</description>
          </group>
          <group group_id="O2">
            <title>Percentage of de Novo Patients at 24 Months</title>
            <description>Percentage of de novo patients for whom pain relief felt before the implantation was &quot;improved&quot; to &quot;very improved&quot; at 24 months</description>
          </group>
        </group_list>
        <measure>
          <title>Patients' Opinion on the Evolution of Pain</title>
          <description>- Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.</description>
          <population>Percentage of de novo patients for whom pain relief before the implantation was &quot;improved&quot; to &quot;very improved&quot; at 12 and 24 months</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="54"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of the Use of Other Pain Treatments</title>
        <description>Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Implanted patients (de novo implants) at 12 months and at 24 months with at least one analgesic treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Rate of primary implanted patients who took at least one analgesic treatment at 1 year</description>
          </group>
          <group group_id="O2">
            <title>Percentage of de Novo Patients at 24 Months</title>
            <description>Rate of primary implanted patients who took at least one analgesic treatment at 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of the Use of Other Pain Treatments</title>
          <description>Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)</description>
          <population>Implanted patients (de novo implants) at 12 months and at 24 months with at least one analgesic treatment</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="56"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of Quality of Life (SF-12) - Physical Score</title>
        <description>Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical &quot;quality of life.</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Percentage of de novo patients with an increase of SF-12 at 12 and 24 months</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Percentage of de novo patients with an increase of SF-12 at 12 months</description>
          </group>
          <group group_id="O2">
            <title>Percentage of de Novo Patients at 24 Months</title>
            <description>Percentage of de novo patients with an increase of SF-12 at 12 months at 24 months</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of Quality of Life (SF-12) - Physical Score</title>
          <description>Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical &quot;quality of life.</description>
          <population>Percentage of de novo patients with an increase of SF-12 at 12 and 24 months</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="50"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients' Willingness to Restart the Treatment</title>
        <description>Patients' willingness to restart the treatment at 12 months and at 24 months.</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Percentage of de novo patients willing to restart treatment at each follow-up (at 1 year and at 2 years)</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Percentage of de novo patients willing to restart treatment at 12 months</description>
          </group>
          <group group_id="O2">
            <title>Percentage of de Novo Patients at 24 Months</title>
            <description>Percentage of de novo patients willing to restart treatment at 24 months</description>
          </group>
        </group_list>
        <measure>
          <title>Patients' Willingness to Restart the Treatment</title>
          <description>Patients' willingness to restart the treatment at 12 months and at 24 months.</description>
          <population>Percentage of de novo patients willing to restart treatment at each follow-up (at 1 year and at 2 years)</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="49"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Anxiety and Depression Disorders</title>
        <description>Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Percentage of de novo patients with anxiety and depression disorders at 12 and 24 months</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Percentage of de novo patients with anxiety and depression at 12 months</description>
          </group>
          <group group_id="O2">
            <title>Percentage of de Novo Patients at 24 Months</title>
            <description>Percentage of de novo patients with anxiety and depression at 24 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Anxiety and Depression Disorders</title>
          <description>Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.</description>
          <population>Percentage of de novo patients with anxiety and depression disorders at 12 and 24 months</population>
          <units>percentage of included de novo patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9" lower_limit="27.6" upper_limit="52.8"/>
                    <measurement group_id="O2" value="45.6" lower_limit="34.6" upper_limit="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of Quality of Life (SF-12) - Mental Score</title>
        <description>Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental &quot;quality of life.</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Percentage of de novo patients with an increase of SF-12 mental score at 12 and 24 months</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Percentage of de novo patients with an increase of SF-12 at 12 months</description>
          </group>
          <group group_id="O2">
            <title>Percentage of de Novo Patients at 24 Months</title>
            <description>Percentage of de novo patients with an increase of SF-12 at 12 months at 24 months</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of Quality of Life (SF-12) - Mental Score</title>
          <description>Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental &quot;quality of life.</description>
          <population>Percentage of de novo patients with an increase of SF-12 mental score at 12 and 24 months</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="50"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.</title>
        <description>The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.</description>
        <time_frame>From baseline until the end of the study at 24 months.</time_frame>
        <population>Implanted patients (de novo implants)</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants)</title>
            <description>Primary outcome measure was estimated only in implanted patients (de novo implants)</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.</title>
          <description>The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.</description>
          <population>Implanted patients (de novo implants)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average pain score for the past 8 days at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="2.2" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average pain score for the past 8 days at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="2.4" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of the Use of Level 3 Analgesics</title>
        <description>Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients</description>
        <time_frame>From baseline until the end of the study at 24 months</time_frame>
        <population>Implanted patients (de novo implants) at 12 months and at 24 months with at least one level 3 analgesic treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Patients (de Novo Implants) at 12 Months</title>
            <description>Posology of level 3 analgesics at 12 months in de novo implanted patients</description>
          </group>
          <group group_id="O2">
            <title>Implanted Patients (de Novo Implants) at 24 Months</title>
            <description>Posology of level 3 analgesics at 24 months in de novo implanted patients .</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of the Use of Level 3 Analgesics</title>
          <description>Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients</description>
          <population>Implanted patients (de novo implants) at 12 months and at 24 months with at least one level 3 analgesic treatment</population>
          <units>MG</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" spread="55.4"/>
                    <measurement group_id="O2" value="55.6" spread="53.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline until the end of the study at 24 months</time_frame>
      <desc>Each investigator reported all adverse events from baseline until the end of the study at 24 months.&#xD;
The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.</desc>
      <group_list>
        <group group_id="E1">
          <title>Overall Population: Implanted and Reimplanted Patients</title>
          <description>Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision</description>
        </group>
        <group group_id="E2">
          <title>Patients With an Event Related to the Device</title>
          <description>Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision and for whom the AE (or SAE) was related to this device</description>
        </group>
      </group_list>
      <serious_events>
        <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="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections</sub_title>
                <counts group_id="E1" events="15" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>electrode displacement / electrode migration</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Neurostimulator migration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Electrode fracture</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Extension fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Undesirable stimulation</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Loss of efficacy</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Difficulty of charging</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Other complications</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Connector problem</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Undesirable stimulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Loss of efficacy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>High impedence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="106"/>
              </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>Study performed in real-life conditions , based on standard of care and some follow-ups were not considered as routine visits.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Stéphane Bouée, Medical director</name_or_title>
      <organization>CEMKA</organization>
      <phone>331.41.87.95.25</phone>
      <email>stephane.bouee@cemka.fr</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/NCT02208999
org study id: 2011045
secondary id: 913018
nct id: NCT02208999
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
Assessing the long-term efficacy, complications, revision rates and final explantation of the
      device
Longitudinal study with a follow-up of 2 years in patients implanted with the Precision
      neurostimulator.

      This study will describe the characterisrics of the patients, of the implantation and will
      assess the long-term efficacy, complications, revision rates and final explantation of the
      device
observational model: Cohort
time perspective: Prospective
measure: Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.
time frame: From baseline until the end of the study at 24 months.
description: Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.
measure: Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.
time frame: From baseline until the end of the study at 24 months.
description: The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.
measure: Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale
time frame: From baseline until the end of the study at 24 months
description: Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:
pain at the present time
usual pain over the past 8 days
the most severe pain in the last 8 days
measure: Patients' Opinion on the Evolution of Pain
time frame: From baseline until the end of the study at 24 months
description: - Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.
measure: Evolution of the Use of Other Pain Treatments
time frame: From baseline until the end of the study at 24 months
description: Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)
measure: Evolution of Quality of Life (SF-12) - Physical Score
time frame: From baseline until the end of the study at 24 months
description: Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical "quality of life.
measure: Patients' Willingness to Restart the Treatment
time frame: From baseline until the end of the study at 24 months
description: Patients' willingness to restart the treatment at 12 months and at 24 months.
measure: Percentage of Patients With Anxiety and Depression Disorders
time frame: From baseline until the end of the study at 24 months
description: Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.
measure: Evolution of Quality of Life (SF-12) - Mental Score
time frame: From baseline until the end of the study at 24 months
description: Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental "quality of life.
measure: Evolution of the Use of Level 3 Analgesics
time frame: From baseline until the end of the study at 24 months
description: Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients
arm group label: Neurostimulator Precision
description: Patients implanted or reimplanted with the neurostimulator Precision
intervention type: Device
intervention name: Neurostimulator Precision
description: All patients included must have been implanted with the neurostimulator Precision
arm group label: Neurostimulator Precision
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elisabeth Dr Mouton, MD
role: Study Director
affiliation: Boston Scientific Corporation
facility: 
country: France
responsible party type: Sponsor
mesh term: Neuralgia
sharing ipd: No
ipd description: Individual participant data will not be shared; Only aggregated data will be communicated
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study performed in real-life conditions , based on standard of care and some follow-ups were not considered as routine visits.
point of contact: 