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

NCT03311269 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-03-02

Study results available
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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.

Conditions

  • Venous Insufficiency

Interventions

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

Sponsors & Collaborators

  • Vascular Insights, LLC

    lead INDUSTRY

Principal Investigators

  • Mark H Meissner, MD · Vascular and Endovascular Surgery Clinic at UWMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2018-05-15
Completion
2020-03-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311269 on ClinicalTrials.gov