<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/NCT04500691</url>
  </required_header>
  <id_info>
    <org_study_id>REPORT</org_study_id>
    <nct_id>NCT04500691</nct_id>
  </id_info>
  <brief_title>pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.</brief_title>
  <acronym>REPORT</acronym>
  <official_title>pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moens Maarten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AZ Nikolaas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the current retrospective study is to predict responders for HF10-SCS therapy by&#xD;
      only using baseline data. Data collected through clinical practice until June 2020 will be&#xD;
      used in this retrospective analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Responder status</measure>
    <time_frame>The difference in pain intensity from the date that a patient was eligible for Spinal Cord Stimulation (i.e. baseline) up to the date of the last routine care visit with Spinal Cord Stimulation with database lock at 15th of June 2020.</time_frame>
    <description>A responder is defined as a patient who has 50% pain relief for the predominant pain location at the last follow-up visit compared to baseline.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">122</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <arm_group>
    <arm_group_label>FBSS patients</arm_group_label>
    <description>FBSS patients who are treated with high frequency Spinal Cord Stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pain intensity reporting</intervention_name>
    <description>pain intensity reporting</description>
    <arm_group_label>FBSS patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with FBSS treated with high frequency spinal cord stimulation implantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FBSS patients treated with high frequency spinal cord stimulation implantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Nikolaas</name>
      <address>
        <city>Sint-Niklaas</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Moens Maarten</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>High frequency Spinal Cord Stimulation</keyword>
  <keyword>prediction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Failed Back Surgery Syndrome</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/NCT04500691
org study id: REPORT
nct id: NCT04500691
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of the current retrospective study is to predict responders for HF10-SCS therapy by
      only using baseline data. Data collected through clinical practice until June 2020 will be
      used in this retrospective analysis.
observational model: Cohort
time perspective: Retrospective
measure: Responder status
time frame: The difference in pain intensity from the date that a patient was eligible for Spinal Cord Stimulation (i.e. baseline) up to the date of the last routine care visit with Spinal Cord Stimulation with database lock at 15th of June 2020.
description: A responder is defined as a patient who has 50% pain relief for the predominant pain location at the last follow-up visit compared to baseline.
arm group label: FBSS patients
description: FBSS patients who are treated with high frequency Spinal Cord Stimulation
intervention type: Other
intervention name: pain intensity reporting
description: pain intensity reporting
arm group label: FBSS patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Moens Maarten
investigator title: Principal Investigator
mesh term: Syndrome
mesh term: Failed Back Surgery Syndrome