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The BRILLIANT Study

NCT00618514 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2015-03-23

Study results available
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Summary

This trial was designed as a prospective, multi-center, randomized clinical trial of the FDA-cleared Vari-Lase Bright Tip Fiber compared to commercially available standard bare-tip laser fiber (control) to demonstrate the safety and effectiveness of laser ablation for the treatment of varicose veins associated with reflux within the great saphenous vein (GSV) and to provide additional data concerning patient satisfaction. Within this evaluation, subject limbs were randomized to one of two (2) treatment groups utilizing a 1:1 randomization ratio. If a subject required treatment of only one limb, that limb was randomized to a treatment group. If a subject required treatment of two limbs, the first limb was randomly assigned treatment and the second limb was assigned the other treatment (the opposite treatment of the other limb). The data was analyzed by treated limb (versus treated subject).All study data were analyzed under the principles of intent-to-treat, in which data are analyzed according to the assigned randomized group regardless of the treatment actually delivered. Subjects were followed at one week, one month, and six months.

Conditions

  • Varicose Veins

Interventions

DEVICE

Bright Tip Laser Fiber

Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber with a fitted ceramic tip on the end. Treatment performed on one leg.

DEVICE

Bare Tip Laser Fiber

Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber readily available on the market with a bare tip on the end. Treatment performed on one leg.

Sponsors & Collaborators

  • Vascular Solutions LLC

    lead INDUSTRY

Principal Investigators

  • Robert Worthington-Kirsch, MD · Image Guided Surgery Associates

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-08-31
Completion
2009-08-31

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 NCT00618514 on ClinicalTrials.gov