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

NCT ID: NCT02462720

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

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.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Varithena®

Intervention Type: DRUG

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

Radiofrequency ablation

Intervention Type: DEVICE

Radiofrequency ablation conducted per physicians' standard of care.

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.

Group Type: ACTIVE_COMPARATOR

Varithena®

Intervention Type: DRUG

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

Radiofrequency ablation

Intervention Type: DEVICE

Radiofrequency ablation conducted per physicians' standard of care.

Interventions

Varithena®

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

Intervention Type: DRUG

Radiofrequency ablation

Radiofrequency ablation conducted per physicians' standard of care.

Intervention Type: DEVICE

Other Intervention Names

Polidocanol Solution, 180 mg/18 mL (10 mg/mL); RFA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wright, MD

Role: STUDY_DIRECTOR

BTG International Inc.

Locations

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

Countries

United States

Other Identifiers

VAP.VV018

Identifier Type: -

Identifier Source: org_study_id