The BRILLIANT Study (BRILLIANT)

March 20, 2015 updated by: Vascular Solutions LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Southeast Vein and Laser
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Morrision Vein Institute
    • Florida
      • Hollywood, Florida, United States, 33021
        • Healthworx
      • Palm Harbor, Florida, United States, 34683
        • Mackay Center for Vein Treatment and Laser Therapy
    • North Carolina
      • Kinston, North Carolina, United States, 28501
        • Comprehensive Wound Care
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Memorial Hospital
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • The Vein Center of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is 18 years of age or older
  2. Subjects with primary varicose veins resultant of GSV reflux documented on duplex ultrasound
  3. Subjects that will be undergoing endovenous laser ablation treatment of varicose veins
  4. Subjects treatment includes the Greater Saphenous Vein
  5. If bilateral, subject is willing and able to undergo treatment of both legs within two weeks.
  6. Subjects who are willing and able to comply with the requirements of the study protocol
  7. Subjects who are willing and able to provide informed consent

Exclusion Criteria:

  1. Subjects with severe peripheral vascular disease (PVD) as evidenced by an ankle-brachial index of < 0.5
  2. Subjects who are unable to ambulate at baseline
  3. Subjects with thrombosis in the vein segment(s) to be treated
  4. Subjects that have had prior vein treatment
  5. Subjects who are known or suspected to be pregnant or lactating
  6. Subjects that are concurrently participating in an investigational study that may confound the treatment or outcomes of the present study
  7. Subjects with an active or systemic infection
  8. Anatomic variants- duplication of the GSV, presence of incompetent accessory veins of the GSV
  9. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
6 Months
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.
6 months
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vascular Solutions LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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