<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/NCT01719055</url>
  </required_header>
  <id_info>
    <org_study_id>A7007</org_study_id>
    <secondary_id>90876777</secondary_id>
    <nct_id>NCT01719055</nct_id>
  </id_info>
  <brief_title>RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain</brief_title>
  <acronym>RELIEF</acronym>
  <official_title>A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for 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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compile characteristics of real-world clinical outcomes for Boston Scientific commercially&#xD;
      approved neurostimulation systems for pain in routine clinical practice, when used according&#xD;
      to the applicable Directions for Use&#xD;
&#xD;
      - and -&#xD;
&#xD;
      To evaluate the economic value and technical performance of Boston Scientific commercially&#xD;
      approved neurostimulation systems for pain in routine clinical practice&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, multi-center, global registry of Boston Scientific&#xD;
      neurostimulation systems for pain.&#xD;
&#xD;
      The study treatment will consist of neurostimulation trial therapy with any commercially&#xD;
      approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects&#xD;
      with a successful trial outcome, may progress to permanent implant of a neurostimulation&#xD;
      system. Individualization of neurostimulation therapy for pain will be determined according&#xD;
      to investigator discretion and site routine care, and in accordance with inclusion and&#xD;
      exclusion criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 19, 2012</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Anticipated">October 2027</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>
  <other_outcome>
    <measure>Percent pain relief</measure>
    <time_frame>up to 36 months follow up</time_frame>
    <description>Percent pain relief of targeted pain at 6, 12, 24 and 36 months follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>Percent pain relief</measure>
    <time_frame>up to 36 months follow up</time_frame>
    <description>Percent pain relief of low back pain at 6, 12, 24 and 36 months follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>Percent pain relief</measure>
    <time_frame>up to 36 months follow up</time_frame>
    <description>Percent pain relief of leg pain at 6, 12, 24 and 36 months follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in QoL</measure>
    <time_frame>up to 36 months follow up</time_frame>
    <description>Change in quality of life as reported by the Subject at 6, 12, 24 and 36 months follow up</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">4800</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Boston Scientific SCS Systems</arm_group_label>
    <description>Subjects permanently implanted with a Boston Scientific neurostimulation systems</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>neurostimulation system</intervention_name>
    <description>Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome</description>
    <arm_group_label>Boston Scientific SCS Systems</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who exhibit an on-label indication for neurostimulation to relieve chronic&#xD;
        intractable pain, according to the Directions for Use, as applicable in each country or&#xD;
        region&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Study candidate is scheduled to be trialed, on-label, with a commercially approved&#xD;
             Boston Scientific neurostimulation system for pain, per local directions for use&#xD;
&#xD;
          -  Signed a valid, IRB/EC-approved informed consent form&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated for Boston Scientific neurostimulation system&#xD;
&#xD;
          -  Currently diagnosed with cognitive impairment, or exhibits any characteristic, that&#xD;
             would limit study candidate's ability to assess pain relief or to complete study&#xD;
             assessments&#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>Natalie Bloom Lyons</last_name>
    <role>Study Director</role>
    <affiliation>Boston Scientific Corporation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gerard Herro, MS</last_name>
    <phone>855-213-9890</phone>
    <email>BSNClinicalTrials@bsci.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diane Keesey</last_name>
    <phone>855-213-9890</phone>
    <email>BSNClinicalTrials@bsci.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Physicians Research Group, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Comprehensive Pain Management Center</name>
      <address>
        <city>Campbell</city>
        <state>California</state>
        <zip>95008</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Coastal Research Institute</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92009</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pain Medicine Associates, Inc.</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Metropolitan Pain Management Consultants Inc.</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Huntley Pain Specialists</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Conejo Pain Specialists</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91362</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>South Lake Pain Institute, Inc</name>
      <address>
        <city>Clermont</city>
        <state>Florida</state>
        <zip>34711</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Florida Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </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>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Advanced Interventional Pain Management and Research Clinic, Inc.</name>
      <address>
        <city>Miami Gardens</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>JM Clinical Research</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Tallahassee Neurological Clinic, PA</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orthopedic Research Foundation</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Pain Care, LLC</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chicago Anesthesia Pain Specialists</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Global Scientific Innovations - Advanced Pain Care Clinic</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Summit Research Institute</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Goodman Campbell Brain and Spine</name>
      <address>
        <city>Greenwood</city>
        <state>Indiana</state>
        <zip>46143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>American Health Network of Indiana, LLC</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Research Medical Center</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66214</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Neuroscience Associates of Northern Kentucky</name>
      <address>
        <city>Crestview Hills</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Bux Pain Management</name>
      <address>
        <city>Danville</city>
        <state>Kentucky</state>
        <zip>40422</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Willis-Knighton River Cities Clinical Research Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Brookline</city>
        <state>Massachusetts</state>
        <zip>02445</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Insight Institute of Neurosurgery &amp; Neuroscience</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jackson Anesthesia Pain Center, LLC</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Midwest Pain Center</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63005</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Saint Louis Pain Consultants</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>KC Pain Centers</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64086</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </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>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Spine and Skeletal Pain Medicine</name>
      <address>
        <city>Utica</city>
        <state>New York</state>
        <zip>13502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Carolinas Research Institute, PLLC</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Raleigh Neurology Associates, P.A.</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Florence Neurosurgery and Spine</name>
      <address>
        <city>Florence</city>
        <state>South Carolina</state>
        <zip>29506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Channel Research</name>
      <address>
        <city>Pawleys Island</city>
        <state>South Carolina</state>
        <zip>29585</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Balcones Pain Consultants</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Spine Works Institute</name>
      <address>
        <city>North Richland Hills</city>
        <state>Texas</state>
        <zip>76182</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Spine Team Texas</name>
      <address>
        <city>Rockwall</city>
        <state>Texas</state>
        <zip>75032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Precision Spine Care</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Washington Center for Pain Management</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>EvergreenHealth Pain Care</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Swedish Neuroscience Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospitals</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Advanced Pain Management Appleton</name>
      <address>
        <city>Greenfield</city>
        <state>Wisconsin</state>
        <zip>53221</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>CENIT Centro de Neurociencias, Investigacion y Tratamiento</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Interventus Pain Specialists</name>
      <address>
        <city>Auchenflower</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hunter Clinical Research</name>
      <address>
        <city>Broadmeadow</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hunter Pain Clinic</name>
      <address>
        <city>Broadmeadow</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Green Lizard Science</name>
      <address>
        <city>Claremont</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sydney Spine and Pain Pty Ltd</name>
      <address>
        <city>Hurstville</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast Clinical Research</name>
      <address>
        <city>Noosa Heads</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pain Matrix</name>
      <address>
        <city>Waurn Ponds</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pain Medicine of South Australia</name>
      <address>
        <city>Wayville</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Lucas</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>AZ Delta</name>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital de Enfant-Jesus</name>
      <address>
        <city>Québec</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Regina General Hospital</name>
      <address>
        <city>Regina</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion Clinica Valle del Lili</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Fundacion Cardiovascular de Colombia Floridablanca</name>
      <address>
        <city>Floridablanca</city>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik Charite Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University KH Bonn</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Dusseldorf</name>
      <address>
        <city>Duesseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Koeln</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Algesiologikum</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat-Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Fondazione Salvatore Maugeri IRCCS</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe-shi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hyogo College of Medicine Hospital</name>
      <address>
        <city>Nishinomiya-shi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sakai Hospital Kinki University Faculty of Medicine</name>
      <address>
        <city>Sakai-shi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Rijnstate</name>
      <address>
        <city>Velp</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital General de Ciudad Real</name>
      <address>
        <city>Ciudad Real</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital La Princesa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Elena</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Donostia</name>
      <address>
        <city>San Sebastián</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>H. Marques De Valdecilla</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen De La Salud</name>
      <address>
        <city>Toledo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital General de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Regionale di Lugano</name>
      <address>
        <city>Viganello</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Basildon and Thurrock University Hospitals NHS</name>
      <address>
        <city>Basildon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital Bristol</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The General Infirmary</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St. Bartholomews Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal National Orthopaedic Hospital</name>
      <address>
        <city>Stanmore</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stimulation</keyword>
  <keyword>implantable</keyword>
  <keyword>pulse generator</keyword>
  <keyword>back pain</keyword>
  <keyword>chronic pain</keyword>
  <keyword>leg pain</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01719055
org study id: A7007
secondary id: 90876777
nct id: NCT01719055
lead sponsor: 
has dmc: No
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially
      approved neurostimulation systems for pain in routine clinical practice, when used according
      to the applicable Directions for Use

      - and -

      To evaluate the economic value and technical performance of Boston Scientific commercially
      approved neurostimulation systems for pain in routine clinical practice
The study is a prospective, multi-center, global registry of Boston Scientific
      neurostimulation systems for pain.

      The study treatment will consist of neurostimulation trial therapy with any commercially
      approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects
      with a successful trial outcome, may progress to permanent implant of a neurostimulation
      system. Individualization of neurostimulation therapy for pain will be determined according
      to investigator discretion and site routine care, and in accordance with inclusion and
      exclusion criteria.
observational model: Cohort
time perspective: Prospective
measure: Percent pain relief
time frame: up to 36 months follow up
description: Percent pain relief of targeted pain at 6, 12, 24 and 36 months follow up
measure: Percent pain relief
time frame: up to 36 months follow up
description: Percent pain relief of low back pain at 6, 12, 24 and 36 months follow up
measure: Percent pain relief
time frame: up to 36 months follow up
description: Percent pain relief of leg pain at 6, 12, 24 and 36 months follow up
measure: Change in QoL
time frame: up to 36 months follow up
description: Change in quality of life as reported by the Subject at 6, 12, 24 and 36 months follow up
arm group label: Boston Scientific SCS Systems
description: Subjects permanently implanted with a Boston Scientific neurostimulation systems
intervention type: Device
intervention name: neurostimulation system
description: Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
arm group label: Boston Scientific SCS Systems
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Natalie Bloom Lyons
role: Study Director
affiliation: Boston Scientific Corporation
last name: Gerard Herro, MS
phone: 855-213-9890
email: BSNClinicalTrials@bsci.com
last name: Diane Keesey
phone: 855-213-9890
email: BSNClinicalTrials@bsci.com
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Active, not recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Active, not recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
country: Argentina
country: Australia
country: Belgium
country: Canada
country: Colombia
country: Denmark
country: Germany
country: Israel
country: Italy
country: Japan
country: Netherlands
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor