Conditions: Varicose Veins
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 35
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Varithena® intervention 2: Radiofrequency ablation
Intervention descriptions: intervention 1: Varithena® treatment in accordance with full prescribing information and instructions for use intervention 2: Radiofrequency ablation conducted per physicians' standard of care.

Protocol document: