<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/NCT03246061</url>
  </required_header>
  <id_info>
    <org_study_id>CIP 0006</org_study_id>
    <nct_id>NCT03246061</nct_id>
  </id_info>
  <brief_title>INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP</brief_title>
  <acronym>CLBP</acronym>
  <official_title>INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Relievant Medsystems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN)&#xD;
      Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back&#xD;
      pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of&#xD;
      the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1).&#xD;
      Participants in the Standard Care Control arm will continue on non-surgical standard care and&#xD;
      will be offered optional crossover after 12 months of follow-up with follow-up of 6 months&#xD;
      post crossover treatment.&#xD;
&#xD;
      The study had a pre-specified Interim Analysis with stopping rules for superiority when&#xD;
      approximately 60% of the randomized participants have completed their 3-month primary&#xD;
      endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim&#xD;
      analysis results and recommended stopping enrollments for superiority and offering early&#xD;
      crossover to the control arm participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN&#xD;
      Ablation arm participants will be approached to participate in a sub study of 3 additional&#xD;
      years of follow-up at their 24 month visit (total of 5 years of follow-up).&#xD;
&#xD;
      Control arm subjects who were originally to be offered optional crossover treatment after the&#xD;
      12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of&#xD;
      176.5 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Actual">January 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>BVN Ablation vs Standard Care Control</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)</measure>
    <time_frame>3 months</time_frame>
    <description>Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured 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). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient.&#xD;
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)</measure>
    <time_frame>3 months post treatment / randomization</time_frame>
    <description>Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline.&#xD;
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>BVN Ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BVN ablation with continued standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continue with non-surgical standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intracept System</intervention_name>
    <description>BVN ablation using radiofrequency energy</description>
    <arm_group_label>BVN Ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Non-surgical standard care</description>
    <arm_group_label>Standard Care Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Skeletally mature subjects at least 25 years of age&#xD;
&#xD;
          -  Chronic lower back pain for at least 6 months&#xD;
&#xD;
          -  Failure to respond to at least 6 months of non-operative conservative management&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radicular pain&#xD;
&#xD;
          -  Current or history of spinal infection&#xD;
&#xD;
          -  Modic changes at vertebral bodies other than L3 to S1&#xD;
&#xD;
          -  Contraindication to MRI&#xD;
&#xD;
          -  Pregnant, lactating or plan to become pregnant in next year&#xD;
&#xD;
          -  Has life expectancy of less than 2 years&#xD;
&#xD;
          -  Compensated injuries or ongoing litigation regarding back pain/injury, or financial&#xD;
             incentive to remain impaired&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven R Garfin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Independent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barrow Brain and Spine</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keck Medicine of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Orthopaedic Surgery</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Back Specialists</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Studies America</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Luke's Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bassett Medical Center</name>
      <address>
        <city>Cooperstown</city>
        <state>New York</state>
        <zip>13326</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigations</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Sports and Spine</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Spine Center</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://intraceptstudy.com</url>
    <description>INTRACEPT Study Website</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <results_first_submitted>November 2, 2020</results_first_submitted>
  <results_first_submitted_qc>November 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2020</results_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Trial results will be published at the completion of the trial</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>End of trial</ipd_time_frame>
    <ipd_access_criteria>To be determined</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03246061/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>420 patients screened for MRI Modic changes at levels L3 to S1 to achieve 140 enrollments. Patients with Modic changes at other levels or who had other primary etiologies for their low back pain (i.e. disc herniation, stenosis, facet joint) were excluded. An independent orthopedic surgeon medical reviewer confirmed eligibility prior to randomization. A pre-specified interim analysis was conducted when 60% of randomized patients completed their 3-month primary endpoint visit.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Basivertebral Nerve (BVN) Ablation</title>
          <description>BVN ablation with non-surgical standard care&#xD;
Intracept System: BVN ablation</description>
        </group>
        <group group_id="P2">
          <title>Standard Care Control</title>
          <description>Continue with non-surgical standard care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Interim Analysis</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Still in follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Basivertebral Nerve (BVN) Ablation</title>
          <description>BVN ablation with standard care&#xD;
Intracept System: BVN ablation</description>
        </group>
        <group group_id="B2">
          <title>Standard Care Control</title>
          <description>Continue standard care</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="51"/>
            <count group_id="B2" value="53"/>
            <count group_id="B3" value="104"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.0" spread="9.0"/>
                    <measurement group_id="B2" value="50.0" spread="11.1"/>
                    <measurement group_id="B3" value="50.0" spread="10.1"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Oswestry Disability Index (ODI)</title>
          <description>Oswestry Disability Index (ODI) total score is 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). The minimally clinically important difference for this tool is considered to be a 10 point reduction from baseline.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.0" spread="11.8"/>
                    <measurement group_id="B2" value="48.1" spread="11.2"/>
                    <measurement group_id="B3" value="46.1" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Visual Analogue Scale (VAS)</title>
          <description>Low Back Pain Visual Analog Scale (VAS). Participant indicated level of low back pain on a 10 point numeric scale with 0 being no pain and 10 being maximum pain. The published minimal clinically important difference for VAS is a 2 point reduction from baseline value.</description>
          <units>units on a scale of 0 to 10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.51" spread="1.31"/>
                    <measurement group_id="B2" value="6.82" spread="1.34"/>
                    <measurement group_id="B3" value="6.67" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)</title>
        <description>Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured 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). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient.&#xD;
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.</description>
        <time_frame>3 months</time_frame>
        <population>Interim Analysis N=104 (pre-specified interim analysis when approximately 60% of randomized participants complete their 3-month primary endpoint</population>
        <group_list>
          <group group_id="O1">
            <title>Basivertebral Never (BVN) Ablation</title>
            <description>BVN ablation with standard care&#xD;
Intracept System: RF ablation</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Control</title>
            <description>Continue with standard care</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)</title>
          <description>Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured 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). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient.&#xD;
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.</description>
          <population>Interim Analysis N=104 (pre-specified interim analysis when approximately 60% of randomized participants complete their 3-month primary endpoint</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.3" lower_limit="-29.6" upper_limit="-21.0"/>
                    <measurement group_id="O2" value="-4.4" lower_limit="-8.7" upper_limit="-0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Interim Analysis p-value for significance of &lt;0.025 for an overall alpha of 0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)</title>
        <description>Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline.&#xD;
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.</description>
        <time_frame>3 months post treatment / randomization</time_frame>
        <population>Interim Analysis population</population>
        <group_list>
          <group group_id="O1">
            <title>Basivertebral Nerve (BVN) Ablation</title>
            <description>BVN ablation with non-surgical standard care&#xD;
Intracept System: BVN ablation</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Control</title>
            <description>Continue with non-surgical standard care</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)</title>
          <description>Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline.&#xD;
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.</description>
          <population>Interim Analysis population</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.46" lower_limit="-4.10" upper_limit="-2.82"/>
                    <measurement group_id="O2" value="-1.02" lower_limit="-1.66" upper_limit="-0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Estimates and p-value from ANCOVA with a factor of treatment group and a covariate of baseline VAS score.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Enrollment through 24 month follow-up</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BVN Ablation</title>
          <description>BVN ablation with continued standard care&#xD;
Intracept System: BVN ablation using radiofrequency energy</description>
        </group>
        <group group_id="E2">
          <title>Standard Care Control</title>
          <description>Continue with non-surgical standard care&#xD;
Standard Care: Non-surgical standard care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </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="16" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Transient Leg Pain</sub_title>
                <description>Temporary leg pain resolved in mean of 42 days</description>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Incisional Pain</sub_title>
                <description>Post procedure incision region discomfort</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Ongoing low back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Disc Herniation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Incomplete Procedure</sub_title>
                <description>Inability to access</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <description>Post anesthesia related urinary retention. Resolved with catheterization.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="74"/>
              </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>
    <point_of_contact>
      <name_or_title>Chris Hilker, Sr. Director Clinical Affairs</name_or_title>
      <organization>Relievant Medsystems</organization>
      <phone>(650) 368-1000</phone>
      <email>chilker@relievant.com</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/NCT03246061
org study id: CIP 0006
nct id: NCT03246061
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN)
      Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back
      pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of
      the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1).
      Participants in the Standard Care Control arm will continue on non-surgical standard care and
      will be offered optional crossover after 12 months of follow-up with follow-up of 6 months
      post crossover treatment.

      The study had a pre-specified Interim Analysis with stopping rules for superiority when
      approximately 60% of the randomized participants have completed their 3-month primary
      endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim
      analysis results and recommended stopping enrollments for superiority and offering early
      crossover to the control arm participants.
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN
      Ablation arm participants will be approached to participate in a sub study of 3 additional
      years of follow-up at their 24 month visit (total of 5 years of follow-up).

      Control arm subjects who were originally to be offered optional crossover treatment after the
      12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of
      176.5 days.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: BVN Ablation vs Standard Care Control
primary purpose: Treatment
masking: None (Open Label)
measure: Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
time frame: 3 months
description: Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured 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). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient.
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
measure: Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)
time frame: 3 months post treatment / randomization
description: Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline.
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
arm group label: BVN Ablation
arm group type: Active Comparator
description: BVN ablation with continued standard care
arm group label: Standard Care Control
arm group type: Active Comparator
description: Continue with non-surgical standard care
intervention type: Device
intervention name: Intracept System
description: BVN ablation using radiofrequency energy
arm group label: BVN Ablation
intervention type: Other
intervention name: Standard Care
description: Non-surgical standard care
arm group label: Standard Care Control
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Steven R Garfin, MD
role: Principal Investigator
affiliation: Independent
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country: United States
url: http://intraceptstudy.com
description: INTRACEPT Study Website
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: Trial results will be published at the completion of the trial
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: End of trial
ipd access criteria: To be determined
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 