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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: Clinical Trial NA study, sponsored by Vascular Solutions.
NCT00618514 is a NA study that was terminated before completion, run by Vascular Solutions. The registered enrollment target is 93 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.
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 |
Why NCT00618514 stopped before completion
NCT00618514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Bright Tip Laser Fiber is the first listed.
NCT00618514 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00618514's enrollment target sits among peer trials
93 937th of 2000 higher than 1,064 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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