Treatment of Lower Extremity Spider Veins With Excel V

NCT01362192 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-01-29

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.

Conditions

  • Telangiectasis
  • Spider Veins

Interventions

DEVICE

532 nm KTP Excel V Laser, manufactured by Cutera, Inc.

The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows: * Spot Size: 5 mm * Fluence: 13-15 J/cm2 * Pulse Duration: 40 ms * Epidermal contact-cooling: 5° Celsius

Sponsors & Collaborators

  • Cutera Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

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 NCT01362192 on ClinicalTrials.gov