Varicose VeinsBRILLIANTNCT00618514
The BRILLIANT Study
A study testing Bright Tip Laser Fiber and Bare Tip Laser Fiber in people with Varicose Veins, run by Vascular Solutions LLC at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Bright Tip Laser Fiber and Bare Tip Laser Fiber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Southeast Vein and Laser
Dothan, Alabama, 36303
HealthwoRx
Hollywood, Florida, 33021
Comprehensive Wound Care
Kinston, North Carolina, 28501
Mackay Center for Vein Treatment and Laser Therapy
Palm Harbor, Florida, 34683
Pottstown Memorial Hospital
Pottstown, Pennsylvania, 19464
Morrision Vein Institute
Scottsdale, Arizona, 85255
The Vein Center of Virginia
Virginia Beach, Virginia, 23452
About this study
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
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.
Read the 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 (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. Subjects were 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 were eligible for treatment in the investigation. Prior to laser treatment and after signing an informed consent form, study eligibility assessments were completed including physical assessment of target limb(s), duplex ultrasound of GSV segment(s) targeted for treatment, symptom assessment, medical history, and digital photos of targeted limbs. Upon enrollment, targeted limbs were randomized at a 1:1 ratio to receive the Vari-lase Bright Tip Fiber or the control treatment. If the subject required treatment of two limbs, the first limb was randomized and the second limb was assigned the other treatment (the opposite treatment of the other limb). Immediately post procedure, subjects were assessed for adverse events and a physical assessment of the treated limb(s) was performed. Subjects were also asked to complete a subject pain and satisfaction questionnaire. Subjects were followed at one week, one month, and six months. Follow-up included a physical assessment of treated limb(s), symptom assessment, adverse event assessment, and completion of a subject pain and satisfaction questionnaire. Additionally, a duplex ultrasound assessment was conducted at one week and six months and digital photos were taken of the treated vein segment(s) at one week and one month. 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.
- Conditions
- Varicose Veins
- Being tested
- Bright Tip Laser Fiber, Bare Tip Laser Fiber
- Keywords
- Varicose Veins, Laser Ablation, Laser Wire Fibers
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Tip Laser FiberDevice
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.
Bare Tip Laser FiberDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bright Tip Laser Fiber - FDA-cleared study device Receives: Device: Bright Tip Laser Fiber |
| 2 | Active comparator | Standard bare tip Laser Fiber - Any commercially available laser device (the control) Receives: Device: Bare Tip Laser Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Months
Secondary outcomes (5)
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).
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.
Measured: 6 Months
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).
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.
Measured: 6 Months
Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.
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.
Measured: 6 Months
Percentage of Subjects Reporting an Excellent Satisfaction Score at 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.
Measured: 6 months
Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.
Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Solutions LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Worthington-Kirsch, MD, Principal investigator, Image Guided Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618514
- Sponsor's protocol ID
- 0407
- Acronym
- BRILLIANT
- Status last verified
- Jun 2013
- First submitted
- 6 Feb 2008
- Last updated
- 23 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00618514
- Acronym / sponsor ID
- BRILLIANT / 0407
- Conditions
- Varicose Veins
- Keywords
- Varicose Veins, Laser Ablation, Laser Wire Fibers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Vascular Solutions LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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. Subjects were 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 were eligible for treatment in the investigation. Prior to laser treatment and after signing an informed consent form, study eligibility assessments were completed including physical assessment of target limb(s), duplex ultrasound of GSV segment(s) targeted for treatment, symptom assessment, medical history, and digital photos of targeted limbs. Upon enrollment, targeted limbs were randomized at a 1:1 ratio to receive the Vari-lase Bright Tip Fiber or the control treatment. If the subject required treatment of two limbs, the first limb was randomized and the second limb was assigned the other treatment (the opposite treatment of the other limb). Immediately post procedure, subjects were assessed for adverse events and a physical assessment of the treated limb(s) was performed. Subjects were also asked to complete a subject pain and satisfaction questionnaire. Subjects were followed at one week, one month, and six months. Follow-up included a physical assessment of treated limb(s), symptom assessment, adverse event assessment, and completion of a subject pain and satisfaction questionnaire. Additionally, a duplex ultrasound assessment was conducted at one week and six months and digital photos were taken of the treated vein segment(s) at one week and one month. 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Bright Tip Laser FiberBright Tip Laser Fiber - FDA-cleared study device |
| 2 | Active comparator | Device: Bare Tip Laser FiberStandard bare tip Laser Fiber - Any commercially available laser device (the control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Tip Laser FiberEndovenous 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. | Device | 1 |
| Bare Tip Laser FiberEndovenous 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. | Device | 2 |
Primary outcome
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.
5 secondary outcomes
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).
Time frame: 6 Months
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).
Time frame: 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
Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.
Time frame: 6 months
Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Worthington-Kirsch, MD principal investigator
Image Guided Surgery Associates
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Tip Laser Fiber and Bare Tip Laser Fiber in people with Varicose Veins, run by Vascular Solutions LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months. (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.