NCT03311269

A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency

A Prospective, Randomized, Controlled, Multi-Center, Double Blind Study of ClariVein RES for Treatment of Venous Insufficiency Associated With Incompetent Saphenous Veins Due to Superficial Venous Reflux

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Vascular Insights, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

VICARES is a prospective randomized, controlled, multi-center, double blind study treating venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium Tetradecyl Sulfate (STS) solution utilizing the ClariVein system.

Detailed description

Approximately 50 subjects diagnosed with an incompetent saphenous vein will be randomized to either 1% STS or 3% STS solution delivered by the ClariVein system under ultrasound guidance. Study duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.

Conditions

• Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	ClariVein RES	ClariVein system
DRUG	Sodium Tetradecyl Sulfate 1% Injection	Sodium Tetradecyl Sulfate STS 1% Injection
DRUG	Sodium Tetradecyl Sulfate 3% Injection	Sodium Tetradecyl Sulfate 3% Injection

Timeline

• Start date: 2017-09-22
• Primary completion: 2018-05-15
• Completion: 2020-03-27
• First posted: 2017-10-17
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study