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NCT00618514 · ClinicalTrials.gov registry record · NA
The BRILLIANT Study
A NA study, sponsored by Vascular Solutions.
- Terminated
- Registry status
- NA
- Development phase
- 93
- Enrollment target
NCT00618514 is a NA study that was terminated before completion, run by Vascular Solutions. The registered enrollment target is 93 participants.
The verdict
NCT00618514, a NA study, was terminated before completion, sponsored by Vascular Solutions.
- TERMINATED
- Registry status
- NA
- Development phase
- 93 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Bright Tip Laser Fiber
- DEVICE Bare Tip Laser Fiber
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00618514
The ClinicalTrials.gov registry entry for NCT00618514 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vascular Solutions, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bright Tip Laser Fiber is the first listed.
NCT00618514 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00618514 about?
NCT00618514 is a clinical study titled "The BRILLIANT Study". 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...
What is the current status of trial NCT00618514?
This trial is currently terminated. It is a NA study. The enrollment target is 93 participants. The study started on 2008-06. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00618514?
The interventions under investigation include: Bright Tip Laser Fiber (DEVICE), Bare Tip Laser Fiber (DEVICE).
Who is sponsoring clinical trial NCT00618514?
This trial is sponsored by Vascular Solutions, which has 7 total clinical trials registered on ClinicalTrials.gov.
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