Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials


The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Vascular Solutions, Inc.
Recruitment status was  Recruiting
Information provided by:
Vascular Solutions, Inc Identifier:
First received: February 6, 2008
Last updated: February 19, 2008
Last verified: February 2008

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.

Condition Intervention
Varicose Veins
Device: Bright Tip Laser Fiber
Device: Bare Tip laser fiber

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Vascular Solutions, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
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)
Arms Assigned Interventions
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

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 have provided written informed consent

Exclusion Criteria:

  1. Subjects with severe peripheral vascular disease (PVD) as evidenced by an ankle-brachial index of < 0.5 (If the subject has evidence of PVD then an ABI should be collected. However, if the subject has no signs of PVD then there will be no need to collect an ABI.)
  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 including stripping and ligation, radiofrequency ablation, laser ablation, sclerotherapy.
  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 GSV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00618514

Contact: Mike Swierzewski, Clinical Research Associate 763-656-4370
Contact: Deborah Neymark, VP, Clinical, Regulatory 763-656-4249

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
HealthwoRx Recruiting
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   
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         
Sponsors and Collaborators
Vascular Solutions, Inc
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 Baptist Health
Principal Investigator: Kenneth Todd, MD Southeast Vein and Laser
  More Information

No publications provided

Responsible Party: Sue Walgren, Director of Clinical Research, Vascular Solutions Inc. Identifier: NCT00618514     History of Changes
Other Study ID Numbers: 0407
Study First Received: February 6, 2008
Last Updated: February 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vascular Solutions, Inc:
Varicose Veins
Laser Ablation
Laser Wire Fibers
Comparison of laser fibers currently available for the treatment of Varicose Veins.

Additional relevant MeSH terms:
Varicose Veins
Cardiovascular Diseases
Vascular Diseases processed this record on March 03, 2015