COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
Condition: Varicose Veins
MeSH terms: Varicose Veins
Intervention: Varithena®; Radiofrequency ablation
Intervention description: Varithena® treatment in accordance with full prescribing information and instructions for use; Radiofrequency ablation conducted per physicians' standard of care.
Intervention MeSH terms: Polidocanol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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:

          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