Trial Outcomes & Findings for The BRILLIANT Study (NCT NCT00618514)

NCT ID: NCT00618514

Last Updated: 2015-03-23

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2015-03-23

Participant Flow

Subjects who had a planned endovenous laser ablation treatment for varicose veins that included treatment of the Greater Saphenous Vein (GSV) were recruited from medical clinics.

93 subjects enrolled, 3 subjects were not randomized because they withdrew consent prior to receiving study procedure; 90 subjects randomized and 110 limbs were assigned treatment.

Participant milestones

Measure	Bright Tip Laser Fiber Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this category had only one limb treated with the Bright tip laser fiber.	Standard Bare Tip Laser Fiber Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this arm had only one limb treated with the bare tip laser fiber (control).	Bright Tip Laser & Bare Tip Laser Subjects that received testament of both limbs using the investigational device (Bright Tip laser) and the control (bare tip laser)
Overall Study STARTED	36	38	16
Overall Study COMPLETED	25	26	12
Overall Study NOT COMPLETED	11	12	4

Reasons for withdrawal

Measure	Bright Tip Laser Fiber Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this category had only one limb treated with the Bright tip laser fiber.	Standard Bare Tip Laser Fiber Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this arm had only one limb treated with the bare tip laser fiber (control).	Bright Tip Laser & Bare Tip Laser Subjects that received testament of both limbs using the investigational device (Bright Tip laser) and the control (bare tip laser)
Overall Study Lost to Follow-up	11	12	4

Baseline Characteristics

The BRILLIANT Study

Baseline characteristics by cohort

Measure	Bright Tip Laser Fiber n=55 Participants Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=55 Participants Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Total n=110 Participants Total of all reporting groups
Age, Continuous	54.4 years STANDARD_DEVIATION 12.7 • n=5 Participants	53.8 years STANDARD_DEVIATION 14.1 • n=7 Participants	54.1 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	55 Limbs n=5 Participants	55 Limbs n=7 Participants	110 Limbs n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

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

Outcome measures

Measure	Bright Tip Laser Fiber n=38 Limbs Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=37 Limbs Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.	36 Limbs	36 Limbs

PRIMARY outcome

Timeframe: 6 Months

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

Outcome measures

Measure	Bright Tip Laser Fiber n=54 Limbs Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=52 Participants Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.	0 Limbs	0 Limbs

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Tip Laser Fiber n=39 Limbs Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=37 Limbs Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).	-64.1 percentage change Standard Deviation 22.5	-59.4 percentage change Standard Deviation 34.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Tip Laser Fiber n=38 Limbs Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=35 Limbs Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).	-39.3 percentage of change Standard Deviation 25.5	-47.1 percentage of change Standard Deviation 19.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Tip Laser Fiber n=40 Limbs Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=36 Limbs Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.	-35.8 percentage of change Standard Deviation 54.8	-44.9 percentage of change Standard Deviation 44.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Tip Laser Fiber n=40 Patients Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=37 Patients Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. Excellent Patient Satisfaction Score	72.5 Percentage of participants	64.9 Percentage of participants
Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. Good Patient Satisfaction Score	15.0 Percentage of participants	29.7 Percentage of participants
Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. Fair Patient Satisfaction Score	7.5 Percentage of participants	2.7 Percentage of participants
Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. Poor Patient Satisfaction Score	5.0 Percentage of participants	2.7 Percentage of participants

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Measure	Bright Tip Laser Fiber n=54 Limbs Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=52 Limbs Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.	2 Limbs	1 Limbs

Adverse Events

Bright Tip Laser Fiber

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Bare Tip Laser Fiber

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bright Tip Laser Fiber n=54 participants at risk Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=52 participants at risk Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
General disorders Death	0.00% 0/54 • 6 Months Subjects were assessed for adverse events at 1-week, 1-month and 6-month follow-up office visits.	1.9% 1/52 • 6 Months Subjects were assessed for adverse events at 1-week, 1-month and 6-month follow-up office visits.

Other adverse events

Measure	Bright Tip Laser Fiber n=54 participants at risk Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.	Standard Bare Tip Laser Fiber n=52 participants at risk Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
Vascular disorders Recanalization	5.6% 3/54 • 6 Months Subjects were assessed for adverse events at 1-week, 1-month and 6-month follow-up office visits.	3.8% 2/52 • 6 Months Subjects were assessed for adverse events at 1-week, 1-month and 6-month follow-up office visits.

Additional Information

Robert Worthington-Kirsch

Image Guided Surgery Associates

Phone: (610) 327-7236

Email: kirsch@igsapc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60