The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein.
To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
43
Varithena® (polidocanol injectable foam) 1%
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Vascular Care Connecticut
Darien, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
Mean change in Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment
Time frame: Baseline to 3-month post treatment
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Vein Healthcare Center
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Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
UT Physicians Cardiothoracic and Vascular Surgery
Houston, Texas, United States
Lake Washington Vascular
Bellevue, Washington, United States