<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/NCT03266107</url>
  </required_header>
  <id_info>
    <org_study_id>CIP 0007 and CIP 0008</org_study_id>
    <nct_id>NCT03266107</nct_id>
  </id_info>
  <brief_title>Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain</brief_title>
  <official_title>A Prospective, Open-Label, Single-Arm 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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, single arm, open label, multi-center study to evaluated the effectiveness of&#xD;
      intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic&#xD;
      low back pain for a minimum of 6 months with conservative care. Participants will receive the&#xD;
      Intracept System procedure to ablate the basivertebral nerve within the vertebral body.&#xD;
      Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI&#xD;
      from L3-S1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2018</start_date>
  <completion_date type="Actual">February 17, 2020</completion_date>
  <primary_completion_date type="Actual">February 17, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Index (ODI) - 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) - 3 Months</measure>
    <time_frame>3 Months</time_frame>
    <description>Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI Responder Rate - 3-Month</measure>
    <time_frame>3 Months</time_frame>
    <description>Number &amp; percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Responder Rate - 3 Month</measure>
    <time_frame>3 Months</time_frame>
    <description>Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI -12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. 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 10 point reduction in ODI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS - 12 Month</measure>
    <time_frame>12 Months</time_frame>
    <description>Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI Responder Rate - 12-Month</measure>
    <time_frame>12 Months</time_frame>
    <description>Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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 10 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Responder Rate - 12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Reduction 50% or More - 12 Month</measure>
    <time_frame>12 Months</time_frame>
    <description>Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BVN Ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intracept</intervention_name>
    <description>Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Skeletally mature subjects at least 25 years of age&#xD;
&#xD;
          -  Chronic low back pain for at least 6 months&#xD;
&#xD;
          -  Failure to respond to at least 6 months of non-operative conservative management&#xD;
&#xD;
          -  Oswestry Disability Index (ODI) at least 30 points&#xD;
&#xD;
          -  Modic changes Type 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or history of vertebral cancer or spinal metastasis&#xD;
&#xD;
          -  History of a fragility fracture&#xD;
&#xD;
          -  Any back pathology related to trauma, evidence of vertebral compression fracture or&#xD;
             other spinal pathology that could affect assessment of response to back pain&#xD;
&#xD;
          -  Disc extrusion or protrusion&#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>Eeric Truumees, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Independent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kevin Macadaeg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Independent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana Spine Group</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seton Spine and Scoliosis Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>November 2, 2020</results_first_submitted>
  <results_first_submitted_qc>December 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2020</results_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vertebrogenic Low Back Pain</keyword>
  <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>Results</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>At the completion of trial</ipd_time_frame>
    <ipd_access_criteria>Written request to study sponsor</ipd_access_criteria>
    <ipd_url>http://relievant.com</ipd_url>
  </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>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03266107/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients for the study were drawn from current low back pain clinic populations, referrals, and patient self-referral at two investigative sites in the U.S. from February 2018 to February 2019. Consecutively identified patients were screened for medical history and review of MRI for Modic/endplate changes and any excluded pain sources.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>Intracept - Intraosseous radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrollment to Procedure</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Failure to Access Due to Hardened Bone</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study stopped prior to Procedure</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3-Month Follow-up Visit</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12-Month Follow-up Visit</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intracept treated population</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>Intracept&#xD;
Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="47"/>
          </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="44.47" spread="8.6"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Oswestry Disability Index (ODI)</title>
          <description>The Oswestry Disability Index (ODI) is a validated questionnaire of low back pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.</description>
          <units>Total score on a scale of 0 to 100</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.13" spread="9.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Visual Analog Scale (VAS) for Low Back Pain</title>
          <description>Visual Analog Scale (VAS) for low back pain is a patient-rated 10-point numeric scale with 0 being no pain and 10 being worst imaginable pain.</description>
          <units>Scale 0 to 10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.82" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Oswestry Disability Index (ODI) - 3 Months</title>
        <description>Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline.</description>
        <time_frame>3 months</time_frame>
        <population>Basivertebral nerve ablation treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation&#xD;
Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>Oswestry Disability Index (ODI) - 3 Months</title>
          <description>Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline.</description>
          <population>Basivertebral nerve ablation treated participants</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.33" spread="12.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale (VAS) - 3 Months</title>
        <description>Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.</description>
        <time_frame>3 Months</time_frame>
        <population>Basivertebral nerve ablation treated participants with a 3 month visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) - 3 Months</title>
          <description>Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.</description>
          <population>Basivertebral nerve ablation treated participants with a 3 month visit</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.79" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODI Responder Rate - 3-Month</title>
        <description>Number &amp; percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points.</description>
        <time_frame>3 Months</time_frame>
        <population>Basivertebral nerve ablation treated participants with a 3 month visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>ODI Responder Rate - 3-Month</title>
          <description>Number &amp; percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points.</description>
          <population>Basivertebral nerve ablation treated participants with a 3 month visit</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS Responder Rate - 3 Month</title>
        <description>Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.</description>
        <time_frame>3 Months</time_frame>
        <population>Basivertebral nerve ablation treated participants with a 3 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation&#xD;
Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Responder Rate - 3 Month</title>
          <description>Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.</description>
          <population>Basivertebral nerve ablation treated participants with a 3 month follow-up visit</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODI -12 Months</title>
        <description>Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. 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 10 point reduction in ODI.</description>
        <time_frame>12 Months</time_frame>
        <population>Basivertebral nerve ablation treated participants with a 12 month visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation&#xD;
Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>ODI -12 Months</title>
          <description>Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. 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 10 point reduction in ODI.</description>
          <population>Basivertebral nerve ablation treated participants with a 12 month visit</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.31" spread="14.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS - 12 Month</title>
        <description>Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.</description>
        <time_frame>12 Months</time_frame>
        <population>Basivertebral nerve ablation treated participants with 12-month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>VAS - 12 Month</title>
          <description>Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.</description>
          <population>Basivertebral nerve ablation treated participants with 12-month follow-up visit</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.31" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ODI Responder Rate - 12-Month</title>
        <description>Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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 10 points.</description>
        <time_frame>12 Months</time_frame>
        <population>Basivertebral ablation treated participants with a 12 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation&#xD;
Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>ODI Responder Rate - 12-Month</title>
          <description>Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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 10 points.</description>
          <population>Basivertebral ablation treated participants with a 12 month follow-up visit</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS Responder Rate - 12 Months</title>
        <description>Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.</description>
        <time_frame>12 Months</time_frame>
        <population>Basivertebral nerve ablation treated participants with a 12 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation&#xD;
Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Responder Rate - 12 Months</title>
          <description>Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.</description>
          <population>Basivertebral nerve ablation treated participants with a 12 month follow-up visit</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS Reduction 50% or More - 12 Month</title>
        <description>Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.</description>
        <time_frame>12 Months</time_frame>
        <population>Basivertebral nerve ablation treated participants with a 12 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>BVN Ablation Radiofrequency ablation of the basivertebral nerve using the Intracept System</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Reduction 50% or More - 12 Month</title>
          <description>Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.</description>
          <population>Basivertebral nerve ablation treated participants with a 12 month follow-up visit</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>BVN Ablation&#xD;
Radiofrequency ablation of the basivertebral nerve using the Intracept System</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="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
              </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="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Radiculitis</sub_title>
                <description>Transient leg pain</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </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>VP Clinical Affairs</name_or_title>
      <organization>Relievant Medsystems Inc.</organization>
      <phone>(650) 368-1000 ext 280</phone>
      <email>dsahr@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/NCT03266107
org study id: CIP 0007 and CIP 0008
nct id: NCT03266107
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of
      intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic
      low back pain for a minimum of 6 months with conservative care. Participants will receive the
      Intracept System procedure to ablate the basivertebral nerve within the vertebral body.
      Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI
      from L3-S1.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oswestry Disability Index (ODI) - 3 Months
time frame: 3 months
description: Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline.
measure: Visual Analog Scale (VAS) - 3 Months
time frame: 3 Months
description: Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.
measure: ODI Responder Rate - 3-Month
time frame: 3 Months
description: Number & percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points.
measure: VAS Responder Rate - 3 Month
time frame: 3 Months
description: Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
measure: ODI -12 Months
time frame: 12 Months
description: Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. 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 10 point reduction in ODI.
measure: VAS - 12 Month
time frame: 12 Months
description: Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
measure: ODI Responder Rate - 12-Month
time frame: 12 Months
description: Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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 10 points.
measure: VAS Responder Rate - 12 Months
time frame: 12 Months
description: Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.
measure: VAS Reduction 50% or More - 12 Month
time frame: 12 Months
description: Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.
arm group label: Treatment
arm group type: Experimental
description: BVN Ablation
intervention type: Device
intervention name: Intracept
description: Radiofrequency ablation of the basivertebral nerve using the Intracept System
arm group label: Treatment
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Eeric Truumees, MD
role: Principal Investigator
affiliation: Independent
last name: Kevin Macadaeg, MD
role: Principal Investigator
affiliation: Independent
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: Results
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: At the completion of trial
ipd access criteria: Written request to study sponsor
ipd url: http://relievant.com
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 