<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/NCT02241707</url>
  </required_header>
  <id_info>
    <org_study_id>NYCSA-2014-01</org_study_id>
    <nct_id>NCT02241707</nct_id>
  </id_info>
  <brief_title>Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?</brief_title>
  <official_title>Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYC Surgical Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYC Surgical Associates</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this proposal, the investigators seek to determine whether a reduced compression after&#xD;
      endovenous ablation procedure in treating superficial venous insufficiency affects the&#xD;
      outcomes. This study involves only the use of the compression stocking post endovenous&#xD;
      ablation procedure and everything else is standard according to current guidelines.&#xD;
&#xD;
      The investigators general strategy will be to determine the role of a minimal post-operative&#xD;
      compression and the status of patient satisfaction including (1) Success closure rate of the&#xD;
      treated vein. (2) Less pain; (3) Easier accepted by the patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All adults with varicose vein who are here in the investigators clinic to seek for endovenous&#xD;
      ablation treatments will be invited to participate in this study. The participation in this&#xD;
      research is entirely voluntary.&#xD;
&#xD;
      A. Each patient is given a code number instead of ID(identification) in the chart. Eligible&#xD;
      patients according to their vein size are divided into following groups using a&#xD;
      computer-generated randomization list:&#xD;
&#xD;
        1. Vein diameter between 5.5 and 6.7 mm, Post-op compression 1 day;&#xD;
&#xD;
        2. Vein diameter between 5.5 and 6.7 mm, Post-op compression 7 days;&#xD;
&#xD;
        3. Vein diameter between 6.8 and 8.5 mm, Post-op compression 3 days;&#xD;
&#xD;
        4. Vein diameter between 6.8 and 8.5 mm, Post-op compression 7 days.&#xD;
&#xD;
      B. Researchers: Data collectors and ultrasound technicians are blinded to the type of&#xD;
      intervention, using code instead of patient's ID. The operating surgeon will not be the one&#xD;
      who collects data. Performing physicians master these endovenous procedure techniques&#xD;
      equally, have performed a minimum of 20 procedures independently.&#xD;
&#xD;
      C. Device: Graduated medical compression hosiery, 15-20mmHg. BrightLife Direct, Washington,&#xD;
      DC. Endovenous ablation device: 1. Radiofrequency Ablation- FDA approval 1999, VNUS RFG2, San&#xD;
      Jose, CA; 2. Endovenous Laser ablation- FDA approval Jan 2002, TVS 1470 by Total Vein System.&#xD;
      Wavelength 1470nm, Nano Laser System device, Houston, TX. These two procedures are standard&#xD;
      care under current guideline.&#xD;
&#xD;
      D. The research takes place over 12 months in total. During that time, it will be necessary&#xD;
      for each patient to come to the clinic 6 times, for 1 hour each. The investigators would like&#xD;
      to meet with every patient 1 week and 1, 3, 6, 12 months after the procedure respectively for&#xD;
      a check-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Since reorganization of the institute, this study is aborted. No patient was recruited.&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Vein closure success rate.</measure>
    <time_frame>up to 12 months.</time_frame>
    <description>Vein closure success rate determined by clinical evidence of symptom improvement and post-procedure duplex ultrasound @ 7 days, 1, 3, 6, 12 months.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Varicose Vein</condition>
  <condition>Venous Insufficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All adults, both male/female, with varicose vein who are here in our clinic to seek for&#xD;
        endovenous ablation treatments will be invited to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 and older&#xD;
&#xD;
          2. Diagnosis - symptoms (pain, burning, itching, cramping, heaviness and tiredness of&#xD;
             leg, restless leg, swelling leg, etc.) and clinical signs (dilated veins,&#xD;
             lipodermatosclerosis, color and texture changes of the skin, edema of leg, wound)&#xD;
             correlates with vein diameter &gt;5.5mm and reflex (&gt;0.5 sec) in the upright position&#xD;
             identified with duplex ultrasound&#xD;
&#xD;
          3. Severity/ classification - CEAP(clinical, etiologic, anatomic, and pathophysiologic) 3&#xD;
             or higher&#xD;
&#xD;
          4. Fail to a minimum of three months of nonoperative management (leg elevation, avoidance&#xD;
             of prolonged standing, weight reduction, daily exercise for 30 min, prescription&#xD;
             strength gradient compression garments, NSAIDs&lt;nonsteroidal antiinflammatory drug&gt;)&#xD;
&#xD;
          5. Post endovenous ablation (VNUS or laser) of the great saphenous vein (GSV) or small&#xD;
             saphenous vein (SSV).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Documented allergy or intolerance to compression hosiery&#xD;
&#xD;
          2. Treated vein greater than 8.5 in diameters.&#xD;
&#xD;
          3. Previous history of DVT(deep venous thrombosis); Known prothrombotic state.&#xD;
&#xD;
          4. Arterial insufficiency as determined by ABI(ankle-brachial index)&lt;0.5.&#xD;
&#xD;
          5. Obesity (BMI &gt;35, class II).&#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>Jianzhong Huang, MD</last_name>
    <role>Study Director</role>
    <affiliation>NYC Surgical Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David A Greuner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYC Surgical Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYC Surgical Associates, 555 Passaic Ave, Suite 10</name>
      <address>
        <city>West Caldwell</city>
        <state>New Jersey</state>
        <zip>07006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>April 27, 2015</last_update_submitted>
  <last_update_submitted_qc>April 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Varicose vein</keyword>
  <keyword>Endovenous ablation</keyword>
  <keyword>Compression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</mesh_term>
    <mesh_term>Varicose Veins</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/NCT02241707
org study id: NYCSA-2014-01
nct id: NCT02241707
lead sponsor: 
has dmc: No
In this proposal, the investigators seek to determine whether a reduced compression after
      endovenous ablation procedure in treating superficial venous insufficiency affects the
      outcomes. This study involves only the use of the compression stocking post endovenous
      ablation procedure and everything else is standard according to current guidelines.

      The investigators general strategy will be to determine the role of a minimal post-operative
      compression and the status of patient satisfaction including (1) Success closure rate of the
      treated vein. (2) Less pain; (3) Easier accepted by the patients.
All adults with varicose vein who are here in the investigators clinic to seek for endovenous
      ablation treatments will be invited to participate in this study. The participation in this
      research is entirely voluntary.

      A. Each patient is given a code number instead of ID(identification) in the chart. Eligible
      patients according to their vein size are divided into following groups using a
      computer-generated randomization list:

        1. Vein diameter between 5.5 and 6.7 mm, Post-op compression 1 day;

        2. Vein diameter between 5.5 and 6.7 mm, Post-op compression 7 days;

        3. Vein diameter between 6.8 and 8.5 mm, Post-op compression 3 days;

        4. Vein diameter between 6.8 and 8.5 mm, Post-op compression 7 days.

      B. Researchers: Data collectors and ultrasound technicians are blinded to the type of
      intervention, using code instead of patient's ID. The operating surgeon will not be the one
      who collects data. Performing physicians master these endovenous procedure techniques
      equally, have performed a minimum of 20 procedures independently.

      C. Device: Graduated medical compression hosiery, 15-20mmHg. BrightLife Direct, Washington,
      DC. Endovenous ablation device: 1. Radiofrequency Ablation- FDA approval 1999, VNUS RFG2, San
      Jose, CA; 2. Endovenous Laser ablation- FDA approval Jan 2002, TVS 1470 by Total Vein System.
      Wavelength 1470nm, Nano Laser System device, Houston, TX. These two procedures are standard
      care under current guideline.

      D. The research takes place over 12 months in total. During that time, it will be necessary
      for each patient to come to the clinic 6 times, for 1 hour each. The investigators would like
      to meet with every patient 1 week and 1, 3, 6, 12 months after the procedure respectively for
      a check-up.
observational model: Case-Control
time perspective: Prospective
measure: Vein closure success rate.
time frame: up to 12 months.
description: Vein closure success rate determined by clinical evidence of symptom improvement and post-procedure duplex ultrasound @ 7 days, 1, 3, 6, 12 months.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jianzhong Huang, MD
role: Study Director
affiliation: NYC Surgical Associates
last name: David A Greuner, MD
role: Principal Investigator
affiliation: NYC Surgical Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Venous Insufficiency
mesh term: Varicose Veins