<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/NCT04449835</url>
  </required_header>
  <id_info>
    <org_study_id>CIP 0014</org_study_id>
    <nct_id>NCT04449835</nct_id>
  </id_info>
  <brief_title>The Intracept Global Registry ( TIGR ) - Pilot Study</brief_title>
  <official_title>The Intracept Global Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Relievant Medsystems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M Squared Associates,Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Relievant Medsystems, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Intracept Global Registry is a prospective, noninterventional, observational global post&#xD;
      market independent data collection of the ongoing effectiveness, safety, and satisfaction&#xD;
      outcomes for patients treated with the Intracept Procedure. This registry will be conducted&#xD;
      according to Good Clinical Practice (GCP) guidelines, including participant verbal informed&#xD;
      consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.&#xD;
&#xD;
      Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator&#xD;
      (PI) and the cross-specialty TIGR Physician Steering Committee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in the registry will have seven study visits over a period of five years (one&#xD;
      prior to procedure and 6 post their procedure). Study visits will be conducted via telephone&#xD;
      by a third-party CRO and independent clinical research coordinators. Participants will be&#xD;
      verbally consented and then evaluated via telephonic study visits at baseline (prior to&#xD;
      procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure.&#xD;
&#xD;
      Primary and secondary objectives are based on patient reported outcomes for functional&#xD;
      improvement, pain reduction, and physical and mental health pre and post procedure. The study&#xD;
      will also look at utilization of injections and pain interventions/surgery for treatment of&#xD;
      low back pain post Intracept.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Pilot Study converted to NCT 05660512 prospective single arm cohort study&#xD;
  </why_stopped>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</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>Oswestry Disability Index (ODI) Reduction</measure>
    <time_frame>3 months post procedure</time_frame>
    <description>Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI) improvement</measure>
    <time_frame>3, 12, 24, 36, 48 and 60 months post procedure</time_frame>
    <description>Mean improvement in ODI scores from baseline (scale 0 to 100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Score</measure>
    <time_frame>3, 12, 24, 36, 48 and 60 months post procedure</time_frame>
    <description>Mean reduction in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)</measure>
    <time_frame>3, 12, 24, 36, 48 and 60 months post procedure</time_frame>
    <description>Percent of responders meeting both thresholds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS 29 Change</measure>
    <time_frame>3, 12, 24, 36, 48 and 60 months post procedure</time_frame>
    <description>Mean change in PROMIS-29 from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injections utilization compared to baseline</measure>
    <time_frame>3, 12, 24, 36, 48 and 60 months post procedure</time_frame>
    <description>Numbers of injections post procedure compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post ablation pain interventions/surgeries</measure>
    <time_frame>3, 12, 24, 36, 48 and 60 months post procedure</time_frame>
    <description>Numbers of pain interventions/surgeries post procedure compared to baseline</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Low Back Pain</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intracept Procedure</intervention_name>
    <description>radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients that have the Intracept procedure and whose treating physician is referring to&#xD;
        the registry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients scheduled for the Intracept procedure and whose treating physician is&#xD;
        referring to the registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#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>Zachary McCormick, MD, FAAPMR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spine and Pain Medicine, University of Utah School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Zack McCormick</investigator_full_name>
    <investigator_title>Assistant Professor and Director of Clinical Spine Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04449835
org study id: CIP 0014
nct id: NCT04449835
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Intracept Global Registry is a prospective, noninterventional, observational global post
      market independent data collection of the ongoing effectiveness, safety, and satisfaction
      outcomes for patients treated with the Intracept Procedure. This registry will be conducted
      according to Good Clinical Practice (GCP) guidelines, including participant verbal informed
      consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.

      Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator
      (PI) and the cross-specialty TIGR Physician Steering Committee.
Participants in the registry will have seven study visits over a period of five years (one
      prior to procedure and 6 post their procedure). Study visits will be conducted via telephone
      by a third-party CRO and independent clinical research coordinators. Participants will be
      verbally consented and then evaluated via telephonic study visits at baseline (prior to
      procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure.

      Primary and secondary objectives are based on patient reported outcomes for functional
      improvement, pain reduction, and physical and mental health pre and post procedure. The study
      will also look at utilization of injections and pain interventions/surgery for treatment of
      low back pain post Intracept.
observational model: Cohort
time perspective: Prospective
measure: Oswestry Disability Index (ODI) Reduction
time frame: 3 months post procedure
description: Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.
measure: Oswestry Disability Index (ODI) improvement
time frame: 3, 12, 24, 36, 48 and 60 months post procedure
description: Mean improvement in ODI scores from baseline (scale 0 to 100)
measure: Numeric Pain Score
time frame: 3, 12, 24, 36, 48 and 60 months post procedure
description: Mean reduction in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)
measure: Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)
time frame: 3, 12, 24, 36, 48 and 60 months post procedure
description: Percent of responders meeting both thresholds
measure: PROMIS 29 Change
time frame: 3, 12, 24, 36, 48 and 60 months post procedure
description: Mean change in PROMIS-29 from baseline
measure: Injections utilization compared to baseline
time frame: 3, 12, 24, 36, 48 and 60 months post procedure
description: Numbers of injections post procedure compared to baseline
measure: Post ablation pain interventions/surgeries
time frame: 3, 12, 24, 36, 48 and 60 months post procedure
description: Numbers of pain interventions/surgeries post procedure compared to baseline
intervention type: Procedure
intervention name: Intracept Procedure
description: radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zachary McCormick, MD, FAAPMR
role: Principal Investigator
affiliation: Spine and Pain Medicine, University of Utah School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Zack McCormick
investigator title: Assistant Professor and Director of Clinical Spine Research
mesh term: Low Back Pain
sharing ipd: No