<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/NCT02236338</url>
  </required_header>
  <id_info>
    <org_study_id>HM11792</org_study_id>
    <nct_id>NCT02236338</nct_id>
  </id_info>
  <brief_title>Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein</brief_title>
  <official_title>Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to perform a randomized, prospective trial comparing the two current&#xD;
      methods of treatment for chronic venous insufficiency, in an effort to evaluate complications&#xD;
      and outcomes for each method, and ultimately, to see if one is superior to the other.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This&#xD;
      condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in&#xD;
      the lower extremities. The most common cause is a refluxing or incompetent Greater Saphenous&#xD;
      Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities&#xD;
      rather than successful transport of the blood back to the heart and lungs. The historical&#xD;
      treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through&#xD;
      the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has&#xD;
      emerged over the last decade and has virtually replaced stripping. This involves advancing a&#xD;
      catheter under ultrasound guidance through the GSV and then advancing a laser fiber or&#xD;
      radiofrequency probe through the catheter. These devices then produce the energy to destroy&#xD;
      the vein as the catheters are slowly pulled back. While both radiofrequency ablation and&#xD;
      laser ablation are accepted treatments, neither technology has been definitively proved to&#xD;
      have fewer complications or superior results. This is in part because very few practices have&#xD;
      the ability to make a head to head comparison between the two technologies and must choose&#xD;
      one or the other secondary to financial constraints. The aim of this study is to perform a&#xD;
      randomized prospective trial comparing the two modalities so that more definitive information&#xD;
      to evaluate complications and outcome can be obtained and then recommendations on which, if&#xD;
      either, technology is superior can be made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">August 11, 2016</completion_date>
  <primary_completion_date type="Actual">August 11, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.</measure>
    <time_frame>Annual follow up, up to 75 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of Acute Complications</measure>
    <time_frame>up to 6 weeks post intervention</time_frame>
    <description>Number of acute complications at one and 6 weeks post intervention</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Post-procedure Pain</measure>
    <time_frame>During post procedure recovery period in clinic, an expected average of 2 hours after surgery.</time_frame>
    <description>Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Objective Post-procedure Bruising</measure>
    <time_frame>During post procedure recovery period in clinic, an expected average of 2 hours after surgery.</time_frame>
    <description>Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Chronic Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser Ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ablation of the Incompetent Greater Saphenous Vein</intervention_name>
    <description>For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</description>
    <arm_group_label>Laser Ablation</arm_group_label>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ClosureFAST radiofrequency catheter</intervention_name>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EVLT 980nm diode laser system</intervention_name>
    <arm_group_label>Laser Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic chronic venous insufficiency.&#xD;
&#xD;
          -  Patients in whom endovenous thermal ablation is clinically indicate.&#xD;
&#xD;
          -  Have previously undergone at least 6 weeks of conservative treatment with compression&#xD;
             stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).&#xD;
&#xD;
          -  Have venous disease that meets CEAP clinical class 2 through 6.&#xD;
&#xD;
          -  Have symptoms secondary to Greater Saphenous Vein insufficiency defined as reverse&#xD;
             flow in the saphenous vein &gt;0.5 seconds after calf compression or while standing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive&#xD;
             of spider vein injections or other cosmetic surface procedures).&#xD;
&#xD;
          -  Have a history of DVT.&#xD;
&#xD;
          -  Have a history of hypercoaguability disorder.&#xD;
&#xD;
          -  Are pregnant or breastfeeding.&#xD;
&#xD;
          -  Are nonambulatory.&#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>Malcolm Sydnor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <results_first_submitted>January 31, 2018</results_first_submitted>
  <results_first_submitted_qc>April 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 14, 2018</results_first_posted>
  <last_update_submitted>April 11, 2018</last_update_submitted>
  <last_update_submitted_qc>April 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic venous insufficiency</keyword>
  <keyword>varicose vein</keyword>
  <keyword>greater saphenous vein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Radiofrequency Ablation</title>
          <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
ClosureFAST radiofrequency catheter</description>
        </group>
        <group group_id="P2">
          <title>Laser Ablation</title>
          <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
EVLT 980nm diode laser system</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Radiofrequency Ablation</title>
          <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
ClosureFAST radiofrequency catheter</description>
        </group>
        <group group_id="B2">
          <title>Laser Ablation</title>
          <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
EVLT 980nm diode laser system</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="100"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47" lower_limit="19" upper_limit="86"/>
                    <measurement group_id="B2" value="48.5" lower_limit="23" upper_limit="86"/>
                    <measurement group_id="B3" value="48" lower_limit="19" upper_limit="86"/>
                  </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="80"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.</title>
        <time_frame>Annual follow up, up to 75 months</time_frame>
        <population>The mean long-term followup in the EVLA group was 44 (12-64) months, and the mean long-term follow-up in the RFA group was 42 (12-75) months.</population>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Ablation</title>
            <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
ClosureFAST radiofrequency catheter</description>
          </group>
          <group group_id="O2">
            <title>Laser Ablation</title>
            <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
EVLT 980nm diode laser system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.</title>
          <population>The mean long-term followup in the EVLA group was 44 (12-64) months, and the mean long-term follow-up in the RFA group was 42 (12-75) months.</population>
          <units>percentage of total participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.3"/>
                    <measurement group_id="O2" value="77.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of Acute Complications</title>
        <description>Number of acute complications at one and 6 weeks post intervention</description>
        <time_frame>up to 6 weeks post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Ablation</title>
            <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
ClosureFAST radiofrequency catheter</description>
          </group>
          <group group_id="O2">
            <title>Laser Ablation</title>
            <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
EVLT 980nm diode laser system</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Acute Complications</title>
          <description>Number of acute complications at one and 6 weeks post intervention</description>
          <units>number of complications</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Post-procedure Pain</title>
        <description>Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.</description>
        <time_frame>During post procedure recovery period in clinic, an expected average of 2 hours after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Ablation</title>
            <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
ClosureFAST radiofrequency catheter</description>
          </group>
          <group group_id="O2">
            <title>Laser Ablation</title>
            <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
EVLT 980nm diode laser system</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Post-procedure Pain</title>
          <description>Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="10"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Objective Post-procedure Bruising</title>
        <description>Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.</description>
        <time_frame>During post procedure recovery period in clinic, an expected average of 2 hours after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Ablation</title>
            <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
ClosureFAST radiofrequency catheter</description>
          </group>
          <group group_id="O2">
            <title>Laser Ablation</title>
            <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
EVLT 980nm diode laser system</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Objective Post-procedure Bruising</title>
          <description>Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="9"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Radiofrequency Ablation</title>
          <description>Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
ClosureFAST radiofrequency catheter</description>
        </group>
        <group group_id="E2">
          <title>Laser Ablation</title>
          <description>Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).&#xD;
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.&#xD;
Ablation of the Incompetent Greater Saphenous Vein: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.&#xD;
EVLT 980nm diode laser system</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Malcolm Sydnor</name_or_title>
      <organization>Virginia Commonwealth University</organization>
      <phone>(804) 828-0534</phone>
      <email>malcolm.sydnor@vcuhealth.org</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/NCT02236338
org study id: HM11792
nct id: NCT02236338
lead sponsor: 
has dmc: No
The aim of this study is to perform a randomized, prospective trial comparing the two current
      methods of treatment for chronic venous insufficiency, in an effort to evaluate complications
      and outcomes for each method, and ultimately, to see if one is superior to the other.
Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This
      condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in
      the lower extremities. The most common cause is a refluxing or incompetent Greater Saphenous
      Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities
      rather than successful transport of the blood back to the heart and lungs. The historical
      treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through
      the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has
      emerged over the last decade and has virtually replaced stripping. This involves advancing a
      catheter under ultrasound guidance through the GSV and then advancing a laser fiber or
      radiofrequency probe through the catheter. These devices then produce the energy to destroy
      the vein as the catheters are slowly pulled back. While both radiofrequency ablation and
      laser ablation are accepted treatments, neither technology has been definitively proved to
      have fewer complications or superior results. This is in part because very few practices have
      the ability to make a head to head comparison between the two technologies and must choose
      one or the other secondary to financial constraints. The aim of this study is to perform a
      randomized prospective trial comparing the two modalities so that more definitive information
      to evaluate complications and outcome can be obtained and then recommendations on which, if
      either, technology is superior can be made.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.
time frame: Annual follow up, up to 75 months
measure: Incidence Rate of Acute Complications
time frame: up to 6 weeks post intervention
description: Number of acute complications at one and 6 weeks post intervention
measure: Incidence of Post-procedure Pain
time frame: During post procedure recovery period in clinic, an expected average of 2 hours after surgery.
description: Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.
measure: Incidence of Objective Post-procedure Bruising
time frame: During post procedure recovery period in clinic, an expected average of 2 hours after surgery.
description: Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.
arm group label: Radiofrequency Ablation
arm group type: Active Comparator
description: Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.
arm group label: Laser Ablation
arm group type: Active Comparator
description: Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device.
intervention type: Procedure
intervention name: Ablation of the Incompetent Greater Saphenous Vein
description: For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
arm group label: Laser Ablation
arm group label: Radiofrequency Ablation
intervention type: Device
intervention name: ClosureFAST radiofrequency catheter
arm group label: Radiofrequency Ablation
intervention type: Device
intervention name: EVLT 980nm diode laser system
arm group label: Laser Ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Malcolm Sydnor, MD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Venous Insufficiency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 