The BRILLIANT Study (BRILLIANT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00618514|
Recruitment Status : Terminated (Sponsor decision)
First Posted : February 20, 2008
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins||Device: Bright Tip Laser Fiber Device: Bare Tip Laser Fiber||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Evaluation of the FDA-Cleared Bright Tip Laser Fiber Versus Commercially Available Bare Laser Fiber (the Control) in the Treatment of Reflux in the Greater Saphenous Vein (GSV) Using Endovenous Laser Therapy|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Active Comparator: 1
Bright Tip Laser Fiber - FDA-cleared study device
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.
Active Comparator: 2
Standard bare tip Laser Fiber - Any commercially available laser device (the control)
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.
- Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months. [ Time Frame: 6 Months ]The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.
- Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months. [ Time Frame: 6 Months ]Each treated limb was clinically evaluated for the presence of a device-related serious adverse event.
- Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS). [ Time Frame: 6 Months ]VCSS is a physician's evaluation of 10 pre-determined clinical signs or attributes of venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, active ulcer duration, active ulcer diameter and compression therapy). Each attribute receives a score from 0-3 (0=absent and 3=severe). The best total overall score is 0 (all ten attributes are absent) and the worse overall score is 30 (all ten attributes are severe). Each treated limb was evaluated and scored at baseline and at 6 months.
- Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS). [ Time Frame: 6 Months ]VDS is a physician's evaluation of a patient's ability to work an eight-hour day with or without a support device (i.e., compressive therapy, limb elevation). The patient is scored on a scale of 0-3 (0=asymptomatic and 3=unable to carry out usual activities (patients activities before the onset of disability due to venous disease) even with compression and/or limb elevation). The score represents the degree of disability caused by the venous disease with the best score being 0 and the worse score being 3. Each treated limb was evaluated and scored at baseline and at 6 months.
- Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores. [ Time Frame: 6 Months ]Each subject completed a questionnaire to rate his/her pain. The scale is from 0-10 (0=no pain and 10=worst pain imaginable). Each treated limb was scored by the patient post-procedure and at 6 months to determine the improvement after treatment at the 6-month time point.
- Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. [ Time Frame: 6 months ]Each subject completed a questionnaire to rate their satisfaction with the laser treatment. The score was reported as excellent, good, fair or poor. The best score of excellent was defined as "I am very satisfied with the laser treatment" and the worse score of poor was defined as "I am not satisfied with the laser treatment." Each treated limb was scored by the patient at 6 months to determine the percent satisfaction at the 6-month time point.
- Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months. [ Time Frame: 6 Months ]Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618514
|United States, Alabama|
|Southeast Vein and Laser|
|Dothan, Alabama, United States, 36303|
|United States, Arizona|
|Morrision Vein Institute|
|Scottsdale, Arizona, United States, 85255|
|United States, Florida|
|Hollywood, Florida, United States, 33021|
|Mackay Center for Vein Treatment and Laser Therapy|
|Palm Harbor, Florida, United States, 34683|
|United States, North Carolina|
|Comprehensive Wound Care|
|Kinston, North Carolina, United States, 28501|
|United States, Pennsylvania|
|Pottstown Memorial Hospital|
|Pottstown, Pennsylvania, United States, 19464|
|United States, Virginia|
|The Vein Center of Virginia|
|Virginia Beach, Virginia, United States, 23452|
|Principal Investigator:||Robert Worthington-Kirsch, MD||Image Guided Surgery Associates|