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Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins

NCT00565604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-01-11

Study results available
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Summary

This trial is designed as a prospective, non randomized, single center clinical trial to determine the safety and efficacy of laser ablation of incompetent perforator veins.

Within this clinical evaluation, fifty (50) limbs will be treated with Vari-Lase ®. A duplex ultrasound will verify the presence or absence of incompetent perforator veins (IPV). In addition, the number, diameter and location of the IPVs will be determined. Limbs with IPVs which measure greater than or equal to 3mm in diameter and are located superior to the foot and distal ankle will be considered for entry into the study.

Conditions

  • Venous Insufficiency

Interventions

DEVICE

Short Catheter Delivery

For treating incompetent perforator veins of the lower extremities

Sponsors & Collaborators

  • Vascular Solutions LLC

    lead INDUSTRY

Principal Investigators

  • Daniel Pepper, MD · Lake Washington Vascular Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00565604 on ClinicalTrials.gov