<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/NCT03255200</url>
  </required_header>
  <id_info>
    <org_study_id>950066</org_study_id>
    <nct_id>NCT03255200</nct_id>
  </id_info>
  <brief_title>ReActiv8 Post Market Surveillance Registry</brief_title>
  <acronym>ReActiv8-C</acronym>
  <official_title>ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mainstay Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mainstay Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To gather data on the long-term safety of ReActiv8 and identify any residual risks by&#xD;
      reporting all Serious Adverse Device Effects as well as performance and health care&#xD;
      utilization through two years post-implant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Low Back Pain - NRS</measure>
    <time_frame>90 days, 180 days, 1 year, 2 years post Activation</time_frame>
    <description>Change in NRS compared to Baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Device Effects</measure>
    <time_frame>Through 2 years post Activation</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReActiv8 Implantable Stimulation System</intervention_name>
    <description>Implantable electrical stimulation system.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population for this registry is persons with chronic low back pain who are&#xD;
        indicated for ReActiv8.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet the Indications for ReActiv8&#xD;
&#xD;
          2. Willing to sign the Informed Consent for the Registry&#xD;
&#xD;
          3. Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.&#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>Stefan Schu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SANA Klinikum Duisburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopadisches Krankenhaus Schloss Werneck</name>
      <address>
        <city>Werneck</city>
        <state>Balthasar-Neumann</state>
        <zip>97440</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BG Klinikum Bergmannstrost</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinisches Versorgungszentrum Steinburg gGmbH</name>
      <address>
        <city>Itzehoe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katholisches Klinikum Koblenz</name>
      <address>
        <city>Koblenz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT03255200
org study id: 950066
nct id: NCT03255200
lead sponsor: 
has dmc: No
To gather data on the long-term safety of ReActiv8 and identify any residual risks by
      reporting all Serious Adverse Device Effects as well as performance and health care
      utilization through two years post-implant.
observational model: Cohort
time perspective: Prospective
measure: Low Back Pain - NRS
time frame: 90 days, 180 days, 1 year, 2 years post Activation
description: Change in NRS compared to Baseline
measure: Serious Adverse Device Effects
time frame: Through 2 years post Activation
intervention type: Device
intervention name: ReActiv8 Implantable Stimulation System
description: Implantable electrical stimulation system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan Schu, MD
role: Principal Investigator
affiliation: SANA Klinikum Duisburg
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain