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

Phase 4

Completed

Conditions: Varicose Veins

Interventions: Drug: Varithena®
Device: Radiofrequency ablation

Registration Number: NCT02462720

Lead Sponsor: Boston Scientific Corporation

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

Detailed Description: A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

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
1. Varithena® contraindication due to known allergy to polidocanol
2. RFA contraindication due to veins being too large
3. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Varithena®, then Radiofrequency Ablation	Radiofrequency ablation	Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used. This was followed by RFA treatment.
Radiofrequency ablation then Varithena	Radiofrequency ablation	RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. This was followed by treatment with Varithena.
Varithena®, then Radiofrequency Ablation	Varithena®	Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used. This was followed by RFA treatment.
Radiofrequency ablation then Varithena	Varithena®	RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. This was followed by treatment with Varithena.

Primary Outcome Measures

Name	Time	Method
Pain	14 day average (0-100)	14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.

Secondary Outcome Measures

Name	Time	Method
Procedural Pain	immediately following procedure	degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine
Patient Preference	8 weeks	Patient preference for RFA or Varithena® using e-diary

Trial Locations

Locations (4): Venous Institute of Buffalo
🇺🇸
Amherst, New York, United States
Lake Washington Vascular
🇺🇸
Bellevue, Washington, United States
Coastal Vascular and Interventional, PLLC
🇺🇸
Pensacola, Florida, United States
Midwest Institute for Minimally Invasive Therapies
🇺🇸
Melrose Park, Illinois, United States