The BRILLIANT Study
Recruitment status was Recruiting
This trial is designed as a prospective, multi-center, randomized clinical trial to evaluate the safety and effectiveness of the Bright Tip Fiber as compared to standard bare laser fibers for the treatment of varicose veins associated with reflux within the GSV.
Within this evaluation, study subjects will be randomized to one of two (2) treatment groups. Fifty (50) percent of the study limbs will be randomized to the Bright Tip Fiber group, while fifty (50) percent will be randomized to the bare fiber group, thus utilizing a 1:1 randomization ratio. All study data will be analyzed under the principles of intent-to-treat, in which data will be analyzed according to the assigned randomized group regardless of the treatment actually delivered.
Subject follow-up will be within 1 week of procedure, 1 month, and 6 months post procedure at the vascular clinic, followed by a 12 month telephone assessment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Comparative Evaluation of the Bright Tip Laser Fiber Versus Bare Laser Fiber in the Treatment of Reflux in the Greater Saphenous Vein (GSV) Using Endovenous Laser Therapy|
- The primary objective of this trial is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated vein segment) of the Bright Tip fiber as compared to standard bare fibers. [ Time Frame: One Year ] [ Designated as safety issue: No ]
- The primary safety objective is to evaluate the incidence rate of device-related Serious Adverse Events (SAEs). [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
- Effectiveness: Based on the reduction of subject symptoms as seen on the VCSS and VDS. [ Time Frame: One Year ] [ Designated as safety issue: No ]
- Subject satisfaction: Based on scoring of the Modified Odom's criteria, post-procedural pain (VAS), and based on post-procedural bruising (Blinded review of digital photos) [ Time Frame: One Year ] [ Designated as safety issue: No ]
- Safety: Incidence rate of device-related non-serious adverse events [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||May 2009|
|Estimated Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Bright Tip Laser Fiber
Device: Bright Tip Laser Fiber
Laser fiber for use in endovenous ablation with a fitted ceramic tip on the end to allow for greater visibility under ultrasound and increased efficiency during procedures
Other Name: Bright Tip Laser Fiber
Active Comparator: 2
Standard bare tip Laser Fiber
Device: Bare Tip laser fiber
Bare tip laser fiber readily available on the market
Other Name: Bare Tip Laser Fiber
This trial is designed as a prospective, multi-center, randomized clinical trial to evaluate the safety and effectiveness of the Bright Tip Fiber as compared to standard bare laser fiber for the treatment of varicose veins associated with reflux within the GSV.
Subjects can be pre-screened utilizing standard of care data (including documented evidence of reflux within the GSV) for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent and be enrolled in the investigation.
Upon study enrollment, the subject will be randomized to receive the Bright Tip fiber and/or a standard bare fiber for use during endovenous laser therapy in the following manner:
- If the subject has one limb to be treated, he/she will be randomized to receive either the Bright Tip fiber or the standard bare fiber.
- If the subject has two limbs to be treated, he/she will be randomized to receive the Bright Tip fiber in one leg and the bare fiber in the other leg.
After enrollment, the subject will undergo endovenous laser therapy, followed by a limited duplex ultrasound of the GSV segment treated if vein diameter or other required data has not been obtained. A physical assessment of the treated limb(s) and an assessment for complications will also be obtained.
All subjects will be required to complete follow-up visits at 1 week, 1 month and 6 months post-procedure for a clinical assessment of the treated segment(s). Assessment of the primary and secondary endpoints will take place at these time points. A telephone follow-up will be conducted at 12 months post procedure in order to supplement the data gathered at six months. Adverse events assessment will be made at each follow-up time point.
From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals.
Assignment of bruising will be completed by a single blinded rater.
|Contact: Mike Swierzewski, Clinical Research Associatefirstname.lastname@example.org|
|Contact: Deborah Neymark, VP, Clinical, Regulatory||763-656-4249||DNeymark@vascularsolutions.com|
|United States, Alabama|
|Southeast Vein and Laser||Recruiting|
|Dothan, Alabama, United States, 36303|
|Contact: Darlene Beech 334-678-9494|
|Principal Investigator: Kenneth Todd, MD|
|United States, Arizona|
|Morrision Vein Institute||Recruiting|
|Scottsdale, Arizona, United States, 85255|
|Contact: Elaine Johnson 480-860-6455|
|Contact: Sharon Olbert 480-860-6455|
|Principal Investigator: Nick Morrison, MD|
|United States, Florida|
|Hollywood, Florida, United States, 33021|
|Contact: Heisy Almonte 954-983-8910|
|Principal Investigator: Yale Cohen, MD|
|Mackay Center for Vein Treatment and Laser Therapy||Recruiting|
|Palm Harbor, Florida, United States, 34683|
|Contact: Jill Lane 727-781-5652|
|Principal Investigator: Edward Mackay, MD|
|United States, North Carolina|
|Comprehensive Wound Care||Recruiting|
|Kinston, North Carolina, United States, 28501|
|Contact: Sandra Jackson 252-527-9928|
|Principal Investigator: Joseph Whitlark, MD|
|United States, Pennsylvania|
|Pottstown Memorial Hospital||Recruiting|
|Pottstown, Pennsylvania, United States, 19464|
|Contact: Robert Worthington-Kirsch, MD email@example.com|
|Principal Investigator: Robert Worthington-Kirsch, MD|
|United States, Utah|
|Intermountain Vein Center||Not yet recruiting|
|Provo, Utah, United States, 84604|
|Contact: Paul Lemon 801-358-5781|
|Principal Investigator: Carl Black, MD|
|United States, Virginia|
|The Vein Center of Virginia||Not yet recruiting|
|Virginia Beach, Virginia, United States, 23452|
|Contact: Jan Devlin 757-470-5571|
|Principal Investigator: F. Noel Parent, MD|
|Sub-Investigator: Scott McEnroe, MD|
|Study Director:||Robert Kirsch, MD||Image Guided Surgery Associates|
|Principal Investigator:||Yale Cohen, MD||HealthwoRx|
|Principal Investigator:||Nick Morrison, MD||Morrison Vein Institute|
|Principal Investigator:||Edward Mackay, MD||Mackay Vein Institute|
|Principal Investigator:||Noel Parent, MD||Vein Center of Virginia|
|Principal Investigator:||Joseph Whitlark, MD||Comprehensive Wound Care|
|Principal Investigator:||Carl Black, MD||Intermountain Vein Center|
|Principal Investigator:||John Regan, MD||Wake Forest University Baptist Medical Center|
|Principal Investigator:||Kenneth Todd, MD||Southeast Vein and Laser|