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Completed

NCT Number: NCT02462720

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

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

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Coastal Vascular and Interventional, PLLC, Pensacola, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Varithena®

Drug

Varithena® treatment in accordance with full prescribing information and instructions for use

Other names: Polidocanol Solution, 180 mg/18 mL (10 mg/mL)

Radiofrequency Ablation

Device

Radiofrequency ablation conducted per physicians' standard of care.

Other names: RFA

Primary outcomes

  1. Pain

    Time frame: 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 outcomes

  1. Procedural Pain

    Time frame: 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

  2. Patient Preference

    Time frame: 8 weeks

    Patient preference for RFA or Varithena® using e-diary

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation

Acronym: COMFORT

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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