<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/NCT02248740</url>
  </required_header>
  <id_info>
    <org_study_id>HM11844</org_study_id>
    <nct_id>NCT02248740</nct_id>
  </id_info>
  <brief_title>Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein</brief_title>
  <official_title>Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small 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 related to the Small Saphenous Vein&#xD;
      (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one&#xD;
      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 second most common cause is a refluxing or incompetent Small&#xD;
      Saphenous Vein (SSV). This condition results in pooling of deoxygenated blood in the lower&#xD;
      extremities rather than successful transport of the blood back to the heart and lungs. The&#xD;
      historical treatment has been to surgically remove or 'strip' the SSV so that blood is&#xD;
      rerouted through the healthier deep veins. A less invasive treatment option, Endovenous&#xD;
      Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This&#xD;
      involves advancing a catheter under ultrasound guidance through the SSV and then advancing a&#xD;
      laser fiber or radiofrequency probe through the catheter. These devices then produce the&#xD;
      energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency&#xD;
      ablation and laser ablation are accepted treatments, neither technology has been definitively&#xD;
      proved to have fewer complications or superior results. This is in part because very few&#xD;
      practices have the ability to make a head to head comparison between the two technologies and&#xD;
      must choose one or the other secondary to financial constraints. The aim of this study is to&#xD;
      perform a randomized prospective trial comparing the two modalities so that more definitive&#xD;
      information to evaluate complications and outcome can be obtained and then recommendations on&#xD;
      which, if either, technology is superior can be made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">March 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 29, 2017</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>Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.</measure>
    <time_frame>At 10 years after treatment.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of Acute Complications</measure>
    <time_frame>1 and 6 weeks post intervention.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Pain and Bruising</measure>
    <time_frame>During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.</time_frame>
    <description>Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10.&#xD;
Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</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 small 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 small saphenous vein, using this device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ablation of the incompetent small saphenous vein</intervention_name>
    <description>For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed 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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic chronic venous insufficiency.&#xD;
&#xD;
          -  Patients in whom endovenous thermal ablation is clinically indicated.&#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 symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow&#xD;
             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 Deep Venous Thrombosis (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>September 2018</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>February 1, 2018</results_first_submitted>
  <results_first_submitted_qc>September 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 7, 2019</results_first_posted>
  <last_update_submitted>September 11, 2018</last_update_submitted>
  <last_update_submitted_qc>September 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic venous insufficiency</keyword>
  <keyword>varicose vein</keyword>
  <keyword>small saphenous vein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 16, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT02248740/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</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="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>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="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.</title>
        <time_frame>At 10 years after treatment.</time_frame>
        <population>No study data was collected prior to study termination.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.</title>
          <population>No study data was collected prior to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of Acute Complications</title>
        <time_frame>1 and 6 weeks post intervention.</time_frame>
        <population>No study data was collected prior to study termination.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Acute Complications</title>
          <population>No study data was collected prior to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Pain and Bruising</title>
        <description>Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10.&#xD;
Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators.</description>
        <time_frame>During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.</time_frame>
        <population>No study data was collected prior to study termination.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Pain and Bruising</title>
          <description>Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10.&#xD;
Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators.</description>
          <population>No study data was collected prior to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</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 small saphenous vein, using this device.&#xD;
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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 Univeristy</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/NCT02248740
org study id: HM11844
nct id: NCT02248740
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 related to the Small Saphenous Vein
      (SSV) 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 second most common cause is a refluxing or incompetent Small
      Saphenous Vein (SSV). 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 SSV 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 SSV 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: Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.
time frame: At 10 years after treatment.
measure: Incidence Rate of Acute Complications
time frame: 1 and 6 weeks post intervention.
measure: Incidence of Pain and Bruising
time frame: During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.
description: Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10.
Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators.
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 small 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 small saphenous vein, using this device.
intervention type: Procedure
intervention name: Ablation of the incompetent small saphenous vein
description: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
arm group label: Laser Ablation
arm group label: Radiofrequency 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
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 