COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
COMFORT
Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation
1 other identifier
interventional
35
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2015
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
January 23, 2018
CompletedApril 21, 2021
April 1, 2021
7 months
May 20, 2015
January 18, 2017
April 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pain
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.
14 day average (0-100)
Secondary Outcomes (2)
Procedural Pain
immediately following procedure
Patient Preference
8 weeks
Study Arms (2)
Varithena®, then Radiofrequency Ablation
EXPERIMENTALVarithena (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.
Radiofrequency ablation then Varithena
ACTIVE COMPARATORRFA 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.
Interventions
Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation conducted per physicians' standard of care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Coastal Vascular and Interventional, PLLC
Pensacola, Florida, 32503, United States
Midwest Institute for Minimally Invasive Therapies
Melrose Park, Illinois, 60160, United States
Venous Institute of Buffalo
Amherst, New York, 14226, United States
Lake Washington Vascular
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lynn Allen
- Organization
- BTG International Inc.
Study Officials
- STUDY DIRECTOR
David Wright, MD
BTG International Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
June 4, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
April 21, 2021
Results First Posted
January 23, 2018
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share