Phase 4
N=35
COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
Varicose Veins
Bottom Line
View on ClinicalTrials.gov: NCT02462720 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Pain — 11.3; 9.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varithena® (Drug); Radiofrequency ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
11.3; 9.5 | — |
| SECONDARY Procedural Pain |
16.4; 17.8 | — |
| SECONDARY Patient Preference |
19; 14 | — |
Summary
The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02462720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.