COMFORT: A Multicenter, Open-label, Randomized, Crossover Study

Completed · Phase 4

Conditions studied: Varicose Veins

In brief

The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.

Key facts

Study ID

NCT02462720

Run by

Boston Scientific Corporation

People needed

35

Starts

2015-05-01

Expected to finish

2016-03-01

Last updated by the study team

2021-04-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women; age 18 to 75 years
• Bilateral incompetence of SFJ (reflux >1 second on duplex ultrasonography) associated with incompetence of the GSV in both legs
• GSV diameter >5 mm measured from the superficial epigastric vein to 10 cm below the SFJ while in a standing position in both legs
• Eligible to receive RFA treatment and Varithena® treatment
• CEAP C2-C5 (inclusive)
• Patient is participating in usual work and home activities with no changes anticipated for the duration of the study
• Ability to comprehend and sign an informed consent and complete study questionnaires written in English
• Ability to reliably use an electronic diary to record pain and analgesic/opioid use in accordance with the protocol

You may not qualify if…

• Prior GSV treatment in either leg
• Non-venous source of pain in either leg that could confound the results of the study
• Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study
• History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound
• Deep venous reflux unless clinically insignificant in comparison to superficial reflux
• Inability to wear post-procedure compression bandaging and stockings
• Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
• Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
• Major co-existing disease (e.g., malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
• Contraindications to Varithena® (e.g., acute thromboembolic disease) or RFA according to the manufacturer's prescribing information
• Varithena® contraindication due to known allergy to polidocanol
• RFA contraindication due to veins being too large
• RFA Contraindication due to veins being too tortuous
• Known allergic response to polidocanol and/or multiple allergic reactions
• Current or history of alcohol or drug abuse
• Pregnant or lactating women
• Women of childbearing potential not using effective contraception for at least one month prior to study treatment and/or unwilling to continue birth control for the duration of the study
• Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening

Where it is running

• Coastal Vascular and Interventional, PLLC — Pensacola, Florida, United States
• Midwest Institute for Minimally Invasive Therapies — Melrose Park, Illinois, United States
• Venous Institute of Buffalo — Amherst, New York, United States
• Lake Washington Vascular — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.