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

• ClinicalTrials.gov Identifier: NCT02462720
• Recruitment Status: Completed
• First Posted: June 4, 2015
• Results First Posted: January 23, 2018
• Last Update Posted: April 21, 2021
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Varicose Veins	Drug: Varithena®; Device: Radiofrequency ablation	Phase 4

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation
• Study Start Date: May 2015
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Varithena®, then 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.	Drug: Varithena®; Varithena® treatment in accordance with full prescribing information and instructions for use; Other Name: Polidocanol Solution, 180 mg/18 mL (10 mg/mL); Device: Radiofrequency ablation; Radiofrequency ablation conducted per physicians' standard of care.; Other Name: RFA
Active Comparator: Radiofrequency ablation then 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.	Drug: Varithena®; Varithena® treatment in accordance with full prescribing information and instructions for use; Other Name: Polidocanol Solution, 180 mg/18 mL (10 mg/mL); Device: Radiofrequency ablation; Radiofrequency ablation conducted per physicians' standard of care.; Other Name: RFA

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior GSV treatment in either leg
2. Non-venous source of pain in either leg that could confound the results of the study
3. Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study
4. History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound
5. Deep venous reflux unless clinically insignificant in comparison to superficial reflux
6. Inability to wear post-procedure compression bandaging and stockings
7. Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
9. 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.)

10. 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
11. Known allergic response to polidocanol and/or multiple allergic reactions
12. Current or history of alcohol or drug abuse
13. Pregnant or lactating women
14. 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
15. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening

Contacts and Locations

Locations

United States, Florida

Coastal Vascular and Interventional, PLLC

Pensacola, Florida, United States, 32503

United States, Illinois

Midwest Institute for Minimally Invasive Therapies

Melrose Park, Illinois, United States, 60160

United States, New York

Venous Institute of Buffalo

Amherst, New York, United States, 14226

United States, Washington

Lake Washington Vascular

Bellevue, Washington, United States, 98004

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Study Director: David Wright, MD; BTG International Inc.

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02462720
• Other Study ID Numbers: VAP.VV018
• First Posted: June 4, 2015
• Results First Posted: January 23, 2018
• Last Update Posted: April 21, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Polidocanol; Sclerosing Solutions; Pharmaceutical Solutions