Status:
TERMINATED
The BRILLIANT Study
Lead Sponsor:
Vascular Solutions LLC
Conditions:
Varicose Veins
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 (contro...
Detailed Description
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 (contro...
Eligibility Criteria
Inclusion
- Subject is 18 years of age or older
- Subjects with primary varicose veins resultant of GSV reflux documented on duplex ultrasound
- Subjects that will be undergoing endovenous laser ablation treatment of varicose veins
- Subjects treatment includes the Greater Saphenous Vein
- If bilateral, subject is willing and able to undergo treatment of both legs within two weeks.
- Subjects who are willing and able to comply with the requirements of the study protocol
- Subjects who are willing and able to provide informed consent
Exclusion
- Subjects with severe peripheral vascular disease (PVD) as evidenced by an ankle-brachial index of \< 0.5
- Subjects who are unable to ambulate at baseline
- Subjects with thrombosis in the vein segment(s) to be treated
- Subjects that have had prior vein treatment
- Subjects who are known or suspected to be pregnant or lactating
- Subjects that are concurrently participating in an investigational study that may confound the treatment or outcomes of the present study
- Subjects with an active or systemic infection
- Anatomic variants- duplication of the GSV, presence of incompetent accessory veins of the GSV
- Subjects who are scheduled to have a bilateral treatment, where one limb is to be enrolled in this study and the second limb that is not treated as part of this study, is treated within two months of the procedure for this study
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00618514
Start Date
June 1 2008
End Date
August 1 2009
Last Update
March 23 2015
Active Locations (7)
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1
Southeast Vein and Laser
Dothan, Alabama, United States, 36303
2
Morrision Vein Institute
Scottsdale, Arizona, United States, 85255
3
HealthwoRx
Hollywood, Florida, United States, 33021
4
Mackay Center for Vein Treatment and Laser Therapy
Palm Harbor, Florida, United States, 34683