<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/NCT03249584</url>
  </required_header>
  <id_info>
    <org_study_id>MDT16075</org_study_id>
    <nct_id>NCT03249584</nct_id>
  </id_info>
  <brief_title>OsteoCool Tumor Ablation Post-Market Study</brief_title>
  <acronym>OPuS One</acronym>
  <official_title>OsteoCool Tumor Ablation Post-Market Study (OPuS One)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedtronicNeuro</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedtronicNeuro</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>
      This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States,&#xD;
      Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of&#xD;
      this study is to collect real-world outcomes among a cohort of patients in the US, EUR and&#xD;
      CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions&#xD;
      involving bone (in the US, patients with metastatic lesions involving the bone must have&#xD;
      failed or were not candidates for standard therapy), and benign bone tumors such as osteoid&#xD;
      osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study&#xD;
      will collect device, procedure and/or therapy related adverse events and device deficiencies.&#xD;
      Lastly, subject outcomes (such as pain relief, quality of life, and function) will be&#xD;
      evaluated using validated assessment measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">July 17, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>
    <intervention_model_description>Enrollment/Baseline visit, OsteoCool procedure visit and 5 post-procedure visits (3 days, 1 week, 1-, 3-, and 6-month clinic visits) and a final post-procedure study visit (12 months) for a total of 8 study related visits.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation</measure>
    <time_frame>From Baseline to 3 months post RF ablation</time_frame>
    <description>Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation</measure>
    <time_frame>From Baseline to 3 months post RF ablation</time_frame>
    <description>Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.&#xD;
The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">218</enrollment>
  <condition>Metastasis Spine</condition>
  <condition>Metastasis to Bone</condition>
  <arm_group>
    <arm_group_label>OsteoCool™ RF Ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo a single OsteoCool™ RF Ablation procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OsteoCool™ RF Ablation</intervention_name>
    <description>The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas.</description>
    <arm_group_label>OsteoCool™ RF Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Candidate for OsteoCool RF ablation per the labeled indication applicable in their&#xD;
             respective country/region&#xD;
&#xD;
          2. A. Metastatic lesions targeted for treatment must be located in the thoracic and/or&#xD;
             lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone&#xD;
             tumors - no restrictions on location of lesion&#xD;
&#xD;
          3. Report worst pain score ≥4/10 at the target treatment site within the past 24 hours&#xD;
&#xD;
          4. Localized pain resulting from no more than two sites total of metastatic disease&#xD;
&#xD;
          5. Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone&#xD;
             tumors)&#xD;
&#xD;
          6. Willing and able to provide a signed and dated informed consent, comply with the study&#xD;
             plan, follow up visits and phone calls&#xD;
&#xD;
          7. At least 18 years old at the time of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A. Implanted with heart pacemaker or other implanted electronic device (Europe and&#xD;
             Canada only)&#xD;
&#xD;
          2. Use of OsteoCool in vertebral body levels C1-C7&#xD;
&#xD;
          3. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index&#xD;
             vertebra or bone&#xD;
&#xD;
          4. Active or incompletely treated local infection at the planned treatment site(s) and/or&#xD;
             systemic infection&#xD;
&#xD;
          5. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy&#xD;
             or neurologic compromise&#xD;
&#xD;
          6. Planned treatment site(s) associated with spinal cord compression or canal compromise&#xD;
             requiring decompression&#xD;
&#xD;
          7. Fractures due to prostatic cancer or other osteoblastic metastases to the spine.&#xD;
             Metastatic lesions originating in the prostate that are osteolytic or mixed origin are&#xD;
             eligible for the study&#xD;
&#xD;
          8. Pregnant, breastfeeding, or plan to become pregnant during the study duration&#xD;
&#xD;
          9. Concurrent participation in another clinical study that may add additional safety&#xD;
             risks and/or confound study results*&#xD;
&#xD;
         10. Any condition that would interfere with the subject's ability to comply with study&#xD;
             instructions or might confound the study interpretation&#xD;
&#xD;
               -  Subjects in concurrent studies can only be enrolled with permission from&#xD;
                  Medtronic. Please contact Medtronic's study manager to determine if the subject&#xD;
                  can be enrolled in both studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandeep Bagla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vascular Institute of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner - University Medical Center Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Jude Medical Center</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</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>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Cumming</city>
        <state>Georgia</state>
        <zip>30041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renown Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas (UT) Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Institute of Virginia</name>
      <address>
        <city>Woodbridge</city>
        <state>Virginia</state>
        <zip>22193</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Science Centre</name>
      <address>
        <city>Toronto</city>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig AöR</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Luxembourg</name>
      <address>
        <city>Luxembourg</city>
        <zip>1210</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Luxembourg</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Hoh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014.</citation>
    <PMID>33129427</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>March 10, 2020</results_first_submitted>
  <results_first_submitted_qc>July 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2020</results_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</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>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>January 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03249584/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>At the time of the primary objective assessment (Apr 2019), 106 subjects were enrolled. Enrollment ended Feb 2020 with 218 total subjects which allowed for assessment of secondary objective and long-term effectiveness and safety.</recruitment_details>
      <pre_assignment_details>12 of 218 subjects exited prior to RF Ablation (RFA) due to failing in/exclusion criteria, withdrawal of consent, etc. 206 total subjects underwent a single OsteoCool™ RFA procedure. For effectiveness, subjects were separated into 2 study Groups (Thoracic/Lumbar and Periacetabulum/Iliac Crest/Sacrum) based on the location of each subject's ablation(s); subjects were combined for safety.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>OsteoCool™ RF Ablation in Thoracic/Lumbar Spine</title>
          <description>Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine.</description>
        </group>
        <group group_id="P2">
          <title>OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum</title>
          <description>Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Month 3</title>
              <participants_list>
                <participants group_id="P1" count="132"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Month 3 Primary/Secondary Objectives</title>
              <participants_list>
                <participants group_id="P1" count="42">As prespecified, the primary objective included the first 42 Thoracic/Lumbar RF Ablation subjects to complete Month 3.</participants>
                <participants group_id="P2" count="15">As prespecified, the secondary objective included all Periacetabulum/Iliac Crest/Sacrum RF Ablation subjects.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Month 6</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="133"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population is based on all subjects treated with RF Ablation.</population>
      <group_list>
        <group group_id="B1">
          <title>OsteoCool™ RF Ablation in Thoracic/Lumbar Spine</title>
          <description>Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine.</description>
        </group>
        <group group_id="B2">
          <title>OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum</title>
          <description>Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.</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="184"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="206"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="184"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.5" spread="13.4"/>
                    <measurement group_id="B2" value="65.3" spread="9.4"/>
                    <measurement group_id="B3" value="63.7" spread="13.0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="184"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="184"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="184"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="184"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="184"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wost Pain Score</title>
          <description>Worst pain score (WPS) at the target treatment site in the previous 24 hours was collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="184"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.8" spread="1.7"/>
                    <measurement group_id="B2" value="7.9" spread="1.4"/>
                    <measurement group_id="B3" value="7.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation</title>
        <description>Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.</description>
        <time_frame>From Baseline to 3 months post RF ablation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OsteoCool™ RF Ablation in Thoracic/Lumbar Spine</title>
            <description>Subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies).</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation</title>
          <description>Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" lower_limit="-5.2" upper_limit="-3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation</title>
        <description>Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.&#xD;
The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.</description>
        <time_frame>From Baseline to 3 months post RF ablation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum</title>
            <description>Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation</title>
          <description>Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.&#xD;
The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" lower_limit="-6.1" upper_limit="-2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From RF Ablation to Month 12.</time_frame>
      <desc>AE data are based on all available safety data (ie, based on 206 total subjects undergoing RF Ablation including 184 in only the thoracic and/or lumbar vertebral body(ies) and 22 in the periacetabulum, iliac crest, and/or sacrum).&#xD;
Device, therapy, and procedure related AEs were considered reportable. Deaths due to underlying malignancy were not considered AE; all deaths were reviewed for causality by a Clinical Events Committee.</desc>
      <group_list>
        <group group_id="E1">
          <title>Total OsteoCool™ RF Ablation</title>
          <description>Subjects underwent a single OsteoCool™ RF Ablation procedure.&#xD;
OsteoCool™ RF Ablation: The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="82" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intra-abdominal fluid collection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
              </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>Participating Institutions may publish the results provided that any such Publication shall be after the multi-center publication is released or presented and shall be provided to Medtronic for review at least 30 days prior to submission or presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eric Grovender</name_or_title>
      <organization>MedtronicNeuro</organization>
      <phone>763-514-4000</phone>
      <email>eric.a.grovender@medtronic.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/NCT03249584
org study id: MDT16075
nct id: NCT03249584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States,
      Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of
      this study is to collect real-world outcomes among a cohort of patients in the US, EUR and
      CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions
      involving bone (in the US, patients with metastatic lesions involving the bone must have
      failed or were not candidates for standard therapy), and benign bone tumors such as osteoid
      osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study
      will collect device, procedure and/or therapy related adverse events and device deficiencies.
      Lastly, subject outcomes (such as pain relief, quality of life, and function) will be
      evaluated using validated assessment measures.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Enrollment/Baseline visit, OsteoCool procedure visit and 5 post-procedure visits (3 days, 1 week, 1-, 3-, and 6-month clinic visits) and a final post-procedure study visit (12 months) for a total of 8 study related visits.
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
time frame: From Baseline to 3 months post RF ablation
description: Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
measure: Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation
time frame: From Baseline to 3 months post RF ablation
description: Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.
arm group label: OsteoCool™ RF Ablation
arm group type: Other
description: Subjects will undergo a single OsteoCool™ RF Ablation procedure.
intervention type: Device
intervention name: OsteoCool™ RF Ablation
description: The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas.
arm group label: OsteoCool™ RF Ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandeep Bagla, MD
role: Principal Investigator
affiliation: Vascular Institute of Virginia
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country: Canada
country: France
country: Germany
country: Luxembourg
country: United States
citation: Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Hoh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014.
PMID: 33129427
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 