Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-04 @ 12:21 AM
Study NCT ID:
NCT03311269
Status:
TERMINATED
Last Update Posted:
2022-03-02
First Post:
2017-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Sponsor:
Vascular Insights, LLC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated for administrative reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VICARES
Brief 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.
Study duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: