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

Study Overview
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Brief Summary
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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
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A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.

Official Title
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Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation

Conditions
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Varicose Veins

Intervention / Treatment
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* Drug: Varithena®
* Device: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varithena®, then Radiofrequency Ablation<br>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. | Drug: Varithena®<br>* Varithena® treatment in accordance with full prescribing information and instructions for use<br>* Other names: Polidocanol Solution, 180 mg/18 mL (10 mg/mL);Device: Radiofrequency ablation<br>* Radiofrequency ablation conducted per physicians' standard of care.<br>* Other names: RFA;|
| Active Comparator: Radiofrequency ablation then Varithena<br>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. | Drug: Varithena®<br>* Varithena® treatment in accordance with full prescribing information and instructions for use<br>* Other names: Polidocanol Solution, 180 mg/18 mL (10 mg/mL);Device: Radiofrequency ablation<br>* Radiofrequency ablation conducted per physicians' standard of care.<br>* Other names: RFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Pain | degree of procedural pain perceived by the patient obtained immediately following the procedure 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 | immediately following procedure | 
| Patient Preference | Patient preference for RFA or Varithena® using e-diary | 8 weeks |