<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/NCT02225223</url>
  </required_header>
  <id_info>
    <org_study_id>DF-14-01</org_study_id>
    <nct_id>NCT02225223</nct_id>
  </id_info>
  <brief_title>Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)</brief_title>
  <acronym>STARRT</acronym>
  <official_title>Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merit Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DFINE Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merit Medical Systems, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate treating painful metastatic lesions in vertebral&#xD;
      bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral&#xD;
      augmentation (VA) prior to or following radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT'&#xD;
      and &quot;No Previous RT&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty Enrolling&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks</measure>
    <time_frame>Mean change from baseline to 6 weeks</time_frame>
    <description>The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks</measure>
    <time_frame>Mean Change from Baseline prior to 6 weeks</time_frame>
    <description>Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory Q3 Worst Pain Score by Visit</measure>
    <time_frame>Week 1, Week 2, Week 6</time_frame>
    <description>The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Metastatic Lesions in Vertebral Bodies</condition>
  <arm_group>
    <arm_group_label>No previous Radiation Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Failed/Refuse further Radiation Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>STAR™ Tumor Ablation System</intervention_name>
    <description>Targeted-radiofrequency ablation (t-RFA)</description>
    <arm_group_label>Failed/Refuse further Radiation Therapy</arm_group_label>
    <arm_group_label>No previous Radiation Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>StabiliT® Vertebral Augmentation System</intervention_name>
    <description>Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
    <arm_group_label>Failed/Refuse further Radiation Therapy</arm_group_label>
    <arm_group_label>No previous Radiation Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patient is ≥ 18 years old,&#xD;
&#xD;
          2. One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and&#xD;
             blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence&#xD;
             of non-painful vertebrae with metastatic lesions in addition to the painful index&#xD;
             vertebrae are allowed)&#xD;
&#xD;
          3. Never received radiation therapy at index level(s) (following consult with radiation&#xD;
             oncologist re: conventional treatment options) OR Received radiation therapy without&#xD;
             adequate relief from metastatic bone pain as determined by the patient and treating&#xD;
             physician, their treating physician would not prescribe additional radiation&#xD;
             treatments, or refuse additional radiation therapy,&#xD;
&#xD;
          4. Brief Pain Inventory (BPI) worst pain score of ≥ 4 (irrespective of medication),&#xD;
&#xD;
          5. Woman of potential childbearing age agrees to a medically effective birth control&#xD;
             method,&#xD;
&#xD;
          6. Life expectancy of ≥ 2 months,&#xD;
&#xD;
          7. Sufficient mental capacity to comply with the protocol requirements,&#xD;
&#xD;
          8. Understands the potential risks and benefits of study participation and is willing to&#xD;
             provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Primary tumors of the bone (e.g., osteosarcoma) at site of index vertebra(e),&#xD;
&#xD;
          2. Benign tumors of the bone (e.g. osteoid osteoma) at site of index vertebra (e),&#xD;
&#xD;
          3. Lesions due to hematologic malignancy (e.g. multiple myeloma at site of the index&#xD;
             vertebra (e),&#xD;
&#xD;
          4. Compromise in the posterior column of the vertebral body or walls of pedicles.&#xD;
&#xD;
          5. Extra-osseous extension of metastatic lesion is &gt;10mm,&#xD;
&#xD;
          6. Nonreversible or uncorrectable coagulopathy. INR should not be &gt;1.5,&#xD;
&#xD;
          7. Platelet count of &lt; 50,000 ,&#xD;
&#xD;
          8. Radiation therapy was completed on the index vertebra(e) ≤ 28 days before enrollment,&#xD;
&#xD;
          9. Change in chemotherapy agent is planned 7 days before or after enrollment (change in&#xD;
             dose(s) permitted),&#xD;
&#xD;
         10. Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty,&#xD;
&#xD;
         11. Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index&#xD;
             vertebra(e),&#xD;
&#xD;
         12. Spinal cord compression or canal compromise requiring decompression,&#xD;
&#xD;
         13. Major surgery of the spine in same region as the index vertebra(e) was performed&#xD;
             within 3 months before enrollment,&#xD;
&#xD;
         14. Major elective surgery to the spine in same region as the index vertebra(e) is planned&#xD;
             within 1 month following the ablation and cement procedure,&#xD;
&#xD;
         15. Requires upper and lower limb surgery that will affect functional outcomes,&#xD;
&#xD;
         16. Significant clinical morbidities (aside from the index vertebra(e) and recurrent&#xD;
             cancer) that may interfere with data collection that affects pain and functional&#xD;
             results,&#xD;
&#xD;
         17. Medical/surgical conditions contrary to the kyphoplasty procedure (e.g., presence of&#xD;
             active or incompletely treated local infection, severe pulmonary insufficiency),&#xD;
&#xD;
         18. Bedridden due to paralysis or neurological decline,&#xD;
&#xD;
         19. Currently pregnant or nursing, or planning pregnancy (in the period up to 6 months)&#xD;
             following the index procedure(s),&#xD;
&#xD;
         20. Known allergy to bone cement,&#xD;
&#xD;
         21. Has a heart pacemaker or other electronic device implants&#xD;
&#xD;
         22. Concurrent participation or participation within the last 30 days prior to enrollment&#xD;
             in any clinical trial with an investigational medicinal drug/chemotherapeutic or&#xD;
             biologic or medical product.&#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>Jack Jennings, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90032-9235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Memorial Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</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>Northwestern University, Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular and Interventional Radiology</name>
      <address>
        <city>La Grange</city>
        <state>Illinois</state>
        <zip>60439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University/Siteman Cancer Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Marks Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Alexandria Hospital</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <results_first_submitted>May 17, 2021</results_first_submitted>
  <results_first_submitted_qc>July 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2021</results_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metastatic lesions</keyword>
  <keyword>vertebral body</keyword>
  <keyword>ablation</keyword>
  <keyword>radiation</keyword>
  <keyword>targeted radio-frequency ablation</keyword>
  <keyword>radio-frequency targeted vertebral augmentation</keyword>
  <keyword>radiofrequency kyphoplasty</keyword>
  <keyword>spine</keyword>
  <keyword>vertebral augmentation</keyword>
  <keyword>kyphoplasty</keyword>
  <keyword>spinal ablation</keyword>
  <keyword>pain</keyword>
  <keyword>quality of life</keyword>
  <keyword>spinal tumors</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>No Previous Radiation Therapy</title>
          <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
        </group>
        <group group_id="P2">
          <title>Failed/Refuse Further Radiation Therapy</title>
          <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Previous Radiation Therapy</title>
          <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
        </group>
        <group group_id="B2">
          <title>Failed/Refuse Further Radiation Therapy</title>
          <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</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="27"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="35"/>
          </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="62.1" spread="15.3"/>
                    <measurement group_id="B2" value="53.4" spread="15.23"/>
                    <measurement group_id="B3" value="60.2" spread="15.52"/>
                  </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="15"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Cancer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Breast Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prostate Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prostate Cancer and Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Small Cell Lung Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Small Cell Lung Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thyroid Cancer</title>
              <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>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Brief Pain Inventory (BPI -Short Form) - 24 hour worst pain</title>
          <description>The BPI asks subjects to rate pain by circling the one number that best describes pain at its worst in the last 24hrs. 0=no pain and 10=pain as bad as (you) can imagine. Results are presented in response to Q3 of the BPI only (i.e. pain at its worst in the last 24hrs). This was accomplished using the BPI short form.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.9" spread="1.93"/>
                    <measurement group_id="B2" value="7.1" spread="1.46"/>
                    <measurement group_id="B3" value="7.7" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks</title>
        <description>The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.</description>
        <time_frame>Mean change from baseline to 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Previous Radiation Therapy</title>
            <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
          </group>
          <group group_id="O2">
            <title>Failed/Refuse Further Radiation Therapy</title>
            <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks</title>
          <description>The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.</description>
          <units>score 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="27"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.48"/>
                    <measurement group_id="O2" value="1.8" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks</title>
        <description>Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.</description>
        <time_frame>Mean Change from Baseline prior to 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Previous Radiation Therapy</title>
            <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
          </group>
          <group group_id="O2">
            <title>Failed/Refuse Further Radiation Therapy</title>
            <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks</title>
          <description>Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.</description>
          <units>score 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="27"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.75"/>
                    <measurement group_id="O2" value="1.5" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory Q3 Worst Pain Score by Visit</title>
        <description>The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.</description>
        <time_frame>Week 1, Week 2, Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Previous Radiation Therapy</title>
            <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
          </group>
          <group group_id="O2">
            <title>Failed/Refuse Further Radiation Therapy</title>
            <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory Q3 Worst Pain Score by Visit</title>
          <description>The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.</description>
          <units>score 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="27"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="3.00"/>
                    <measurement group_id="O2" value="4.9" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="3.05"/>
                    <measurement group_id="O2" value="5.3" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.87"/>
                    <measurement group_id="O2" value="3.8" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected through time of (early) study termination due to lack of enrollment, through 6 months.</time_frame>
      <desc>All cause mortality was collected. Of 35 enrolled subjects, 9 died due to disease progression and 2 died due to other reasons (one was listed as hospice and the other as &quot;unknown&quot;). There were 0 participants considered to have experienced Serious Adverse Events (SAEs) and the participants who died due to disease progression and other reasons are not considered SAEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>No Previous Radiation Therapy</title>
          <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</description>
        </group>
        <group group_id="E2">
          <title>Failed/Refuse Further Radiation Therapy</title>
          <description>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.&#xD;
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)&#xD;
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)</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="10" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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>
    <limitations_and_caveats>Study was terminated due to difficulty with enrollment. Analysis of data is limited due to early termination of study and incomplete enrollment and completion of study subjects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Casey Holland</name_or_title>
      <organization>Merit Medical</organization>
      <phone>1 (617) 842-0251</phone>
      <email>casey.holland@merit.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/NCT02225223
org study id: DF-14-01
nct id: NCT02225223
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral
      bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral
      augmentation (VA) prior to or following radiation therapy.
Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT'
      and "No Previous RT"
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks
time frame: Mean change from baseline to 6 weeks
description: The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.
measure: Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks
time frame: Mean Change from Baseline prior to 6 weeks
description: Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.
measure: Brief Pain Inventory Q3 Worst Pain Score by Visit
time frame: Week 1, Week 2, Week 6
description: The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.
arm group label: No previous Radiation Therapy
arm group type: Other
description: Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
arm group label: Failed/Refuse further Radiation Therapy
arm group type: Other
description: Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
intervention type: Device
intervention name: STAR™ Tumor Ablation System
description: Targeted-radiofrequency ablation (t-RFA)
arm group label: Failed/Refuse further Radiation Therapy
arm group label: No previous Radiation Therapy
intervention type: Device
intervention name: StabiliT® Vertebral Augmentation System
description: Radiofrequency-targeted vertebral augmentation (RF-TVA)
arm group label: Failed/Refuse further Radiation Therapy
arm group label: No previous Radiation Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jack Jennings, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was terminated due to difficulty with enrollment. Analysis of data is limited due to early termination of study and incomplete enrollment and completion of study subjects.
point of contact: 