Clinical trial NCT02462720: COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
Official title: Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicose Veins
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain
timeFrame: 14 day average (0-100)
Secondary outcomes:
measure: Procedural Pain
timeFrame: immediately following procedure
measure: Patient Preference
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional, PLLC
state: Florida
city: Melrose Park
country: United States
facility: Midwest Institute for Minimally Invasive Therapies
state: Illinois
city: Amherst
country: United States
facility: Venous Institute of Buffalo
state: New York
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
Study officials:
affiliation: BTG International Inc.
name: David Wright, MD
role: STUDY_DIRECTOR
References: