<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/NCT02217150</url>
  </required_header>
  <id_info>
    <org_study_id>PCS</org_study_id>
    <secondary_id>20130370</secondary_id>
    <nct_id>NCT02217150</nct_id>
  </id_info>
  <brief_title>The STAR Prospective Clinical Series</brief_title>
  <acronym>PCS</acronym>
  <official_title>The DFINE STAR™ Tumor Ablation Prospective Clinical Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DFINE Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merit Medical Systems, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective clinical series to gather post tumor ablation clinical outcomes from subjects&#xD;
      with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment&#xD;
      with the STAR™ Tumor Ablation System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Change in Pain</measure>
    <time_frame>1 month</time_frame>
    <description>Mean change from baseline in worst pain score per NRPS at one month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change if Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Function</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline at each visit using Modified Oswestry Disability Index (MODI)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Metastasis to Vertebral Column</condition>
  <arm_group>
    <arm_group_label>Metastatic Lesions to the spine</arm_group_label>
    <description>Patients over the age of 18 receiving treatment using the DFINE Inc. STAR tumor ablation system for palliation of painful metastases of the spine.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation&#xD;
        System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal&#xD;
             procedures by ablation of metastatic malignant lesions in a vertebral body.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The device is contraindicated in subjects with heart pacemakers, or other electronic&#xD;
             device implants.&#xD;
&#xD;
          -  The device is contraindicated in vertebral body levels C1-7.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandeep Bagla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inova Alexandria Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Palomar Pomerado Health System</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</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>Suburban Hospital</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Radiological Associates</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mark's 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 Hospital</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02217150
org study id: PCS
secondary id: 20130370
nct id: NCT02217150
lead sponsor: 
has dmc: No
Prospective clinical series to gather post tumor ablation clinical outcomes from subjects
      with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment
      with the STAR™ Tumor Ablation System.
observational model: Cohort
time perspective: Prospective
measure: Change in Pain
time frame: 1 month
description: Mean change from baseline in worst pain score per NRPS at one month
measure: Change in Quality of Life
time frame: 3 months
description: Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP)
measure: Change if Quality of Life
time frame: 3 months
description: Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7)
measure: Change in Function
time frame: 3 months
description: Change from baseline at each visit using Modified Oswestry Disability Index (MODI)
arm group label: Metastatic Lesions to the spine
description: Patients over the age of 18 receiving treatment using the DFINE Inc. STAR tumor ablation system for palliation of painful metastases of the spine.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Sandeep Bagla, MD
role: Principal Investigator
affiliation: Inova Alexandria Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasm Metastasis