<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/NCT01722019</url>
  </required_header>
  <id_info>
    <org_study_id>2012/693</org_study_id>
    <nct_id>NCT01722019</nct_id>
  </id_info>
  <brief_title>Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.</brief_title>
  <acronym>VNUS vs TULIP</acronym>
  <official_title>Prospective Multicentric Randomised Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diod Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Venous Forum.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Benelux Society of Phlebology.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open&#xD;
      crossectomy and stripping. The two most performed techniques for endovenous ablation are the&#xD;
      endovenous laser ablation and the radiofrequency ablation. According to the trial of&#xD;
      Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in&#xD;
      more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in&#xD;
      observational studies. The aim of this study is to compare radiofrequency ablation with the&#xD;
      VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new&#xD;
      fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point&#xD;
      necroses of the vessel wall and on consequence results in lesser side effects from wall&#xD;
      perforations such as pain, haematoma,…&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Closure of the greater saphenous vein at 12 months.</measure>
    <time_frame>12 months after procedure</time_frame>
    <description>Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain.</measure>
    <time_frame>after 5 days</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain.</measure>
    <time_frame>after 14 days</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain.</measure>
    <time_frame>after 1 month</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain.</measure>
    <time_frame>after 6 months</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain.</measure>
    <time_frame>after 1 year.</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction rate.</measure>
    <time_frame>after 5 days</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction rate.</measure>
    <time_frame>After 14 days.</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction rate.</measure>
    <time_frame>After 1 month</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain satisfaction rate.</measure>
    <time_frame>After 6 months</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction rate.</measure>
    <time_frame>After 1 year.</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incapacity to work.</measure>
    <time_frame>after 5 days</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incapacity to work.</measure>
    <time_frame>After 14 days</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incapacity to work.</measure>
    <time_frame>After 1 month</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incapacity to work.</measure>
    <time_frame>After 6 months</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incapacity to work.</measure>
    <time_frame>After 1 year</time_frame>
    <description>This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Chronic Venous Insufficiency C2 or Higher</condition>
  <arm_group>
    <arm_group_label>radiofrequency ablation with VNUS closure fast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Radiofrequency ablation will be performed with VNUS closure fast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laser ablation and Tulip fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tulip fiber</intervention_name>
    <description>Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.</description>
    <arm_group_label>laser ablation and Tulip fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VNUS closure fast</intervention_name>
    <description>Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.</description>
    <arm_group_label>radiofrequency ablation with VNUS closure fast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Endovenous ablation of the great saphenous vein (GSV) planned&#xD;
&#xD;
          -  Patient signed informed consent&#xD;
&#xD;
          -  Patient must complete the 1 year follow-up&#xD;
&#xD;
          -  CEAP between 2 and 6&#xD;
&#xD;
          -  BMI=&lt;35&#xD;
&#xD;
          -  Diameter of the GSV in upward position less than 20 mm diameter&#xD;
&#xD;
          -  No problems in deep venous system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent is signed&#xD;
&#xD;
          -  Latex allergy&#xD;
&#xD;
          -  Arterial insufficiency&#xD;
&#xD;
          -  Deep vein thrombosis or deep vein insufficiency&#xD;
&#xD;
          -  Klippel Trenaunay&#xD;
&#xD;
          -  Diameter fo GSV &gt; 20 mm&#xD;
&#xD;
          -  Cross dilation with 2 or more insufficient side branches&#xD;
&#xD;
          -  Previous GSV operation&#xD;
&#xD;
          -  Redo-operation&#xD;
&#xD;
          -  Carcinoma less than 1 year ago&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
&#xD;
          -  Liver-insufficiency with contraindication for local tumescence&#xD;
&#xD;
          -  Intake of warfarins&#xD;
&#xD;
          -  Pregnancy, breastfeeding, &lt; 3 months after pregnancy&#xD;
&#xD;
          -  Bilateral GSV insufficiency that has to be treated&#xD;
&#xD;
          -  Cross insufficiency of the accessory saphenous vein or insufficiency of the&#xD;
             subterminal valve of the GSV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carend Randon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint-Andriesziekenhuis Tielt</name>
      <address>
        <city>Tielt</city>
        <zip>8700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.uzgent.be</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>venous insufficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</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/NCT01722019
org study id: 2012/693
nct id: NCT01722019
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open
      crossectomy and stripping. The two most performed techniques for endovenous ablation are the
      endovenous laser ablation and the radiofrequency ablation. According to the trial of
      Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in
      more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in
      observational studies. The aim of this study is to compare radiofrequency ablation with the
      VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new
      fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point
      necroses of the vessel wall and on consequence results in lesser side effects from wall
      perforations such as pain, haematoma,…
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Closure of the greater saphenous vein at 12 months.
time frame: 12 months after procedure
description: Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months.
measure: Pain.
time frame: after 5 days
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Pain.
time frame: after 14 days
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Pain.
time frame: after 1 month
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Pain.
time frame: after 6 months
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Pain.
time frame: after 1 year.
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Patient satisfaction rate.
time frame: after 5 days
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Patient satisfaction rate.
time frame: After 14 days.
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Patient satisfaction rate.
time frame: After 1 month
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Pain satisfaction rate.
time frame: After 6 months
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Patient satisfaction rate.
time frame: After 1 year.
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Incapacity to work.
time frame: after 5 days
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Incapacity to work.
time frame: After 14 days
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Incapacity to work.
time frame: After 1 month
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Incapacity to work.
time frame: After 6 months
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
measure: Incapacity to work.
time frame: After 1 year
description: This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
arm group label: radiofrequency ablation with VNUS closure fast
arm group type: Active Comparator
description: Radiofrequency ablation will be performed with VNUS closure fast.
arm group label: laser ablation and Tulip fiber
arm group type: Experimental
description: Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber.
intervention type: Device
intervention name: Tulip fiber
description: Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.
arm group label: laser ablation and Tulip fiber
intervention type: Device
intervention name: VNUS closure fast
description: Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.
arm group label: radiofrequency ablation with VNUS closure fast
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Carend Randon, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Ghent
facility: 
facility: 
facility: 
country: Belgium
url: http://www.uzgent.be
description: Related Info
responsible party type: Sponsor
mesh term: Venous Insufficiency