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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation; BTG International Inc.
• Treatments: Polidocanol

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