The BRILLIANT Study

NCT00618514 | Terminated Results

• 1 other identifier: 0407
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 7

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 (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.

Conditions

Varicose Veins

Keywords

Varicose Veins; Laser Ablation; Laser Wire Fibers

Outcome Measures

Primary Outcomes (2)

• Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.

  The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.

  6 Months

• Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.

  Each treated limb was clinically evaluated for the presence of a device-related serious adverse event.

  6 Months

Secondary Outcomes (5)

• Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).

  6 Months

• Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).

  6 Months

• Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.

  6 Months

• Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.

  6 months

• Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.

  6 Months

Study Arms (2)

1

ACTIVE COMPARATOR

Bright Tip Laser Fiber - FDA-cleared study device

Device: Bright Tip Laser Fiber

2

ACTIVE COMPARATOR

Standard bare tip Laser Fiber - Any commercially available laser device (the control)

Device: Bare Tip Laser Fiber

Interventions

Bright Tip Laser Fiber DEVICE

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.

1

Bare Tip Laser Fiber DEVICE

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Solutions LLC: lead

Study Sites (7)

Southeast Vein and Laser

Dothan, Alabama, 36303, United States

Location

Morrision Vein Institute

Scottsdale, Arizona, 85255, United States

Location

HealthwoRx

Hollywood, Florida, 33021, United States

Location

Mackay Center for Vein Treatment and Laser Therapy

Palm Harbor, Florida, 34683, United States

Location

Comprehensive Wound Care

Kinston, North Carolina, 28501, United States

Location

Pottstown Memorial Hospital

Pottstown, Pennsylvania, 19464, United States

Location

The Vein Center of Virginia

Virginia Beach, Virginia, 23452, United States

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Due to budgetary constraints, enrollment in the BRILLIANT trial was ended after 90 subjects (110 limbs) were enrolled in the study. This study had an insufficient sample size to perform the planned formal statistical hypothesis testing.

Results Point of Contact

• Title: Robert Worthington-Kirsch
• Organization: Image Guided Surgery Associates

kirsch@igsapc.com

(610) 327-7236

Study Officials

• Robert Worthington-Kirsch, MD

  Image Guided Surgery Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 20, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 23, 2015
• Results First Posted: March 23, 2015

Record last verified: 2013-06

Locations

US (7)