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Treatment of Saphenous Vein Reflux With 1920-nm Diode Laser

NCT02504684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2015-07-22

No results posted yet for this study

Summary

Objective: Compare venous occlusion rates at a one-year follow-up comparing 1920-nm versus 1470-nm laser treatment. Design: Non-randomized prospective study. Methods: Adult patients with varicose veins associated with great saphenous reflux were included. Procedures were performed between February and April of 2013. The 1470-nm laser ablation was performed in continuous mode, power being set between 8 and 10 W, while for the 1920-nm it was set between 5 and 6 W. Checking for vein closure was performed during the thermal ablation procedure, LEED (linear endovenous energy density) being calculated after the procedure. Follow-up data were collected at the 7-day, 30-day, 3-month, 6-month and 1-year visits, and involved clinical and ultrasound evaluation, measurement of occlusion extent.

Conditions

  • Varicose Veins

Interventions

DEVICE

Endovenous 1920-nm diode laser

Patients with saphenous veins treated with a new 1920-nm diode endolaser.

DEVICE

Endovenous 1470-nm diode laser

Patients with saphenous veins treated with the standard 1470-nm diode endolaser.

Sponsors & Collaborators

  • Instituto Vascular BH

    lead OTHER

Principal Investigators

  • Daniel M Pinto, MD · Instituto Vascular BH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Brazil

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 NCT02504684 on ClinicalTrials.gov