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The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation

NCT03037827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2021-05-20

No results posted yet for this study

Summary

A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. From many studies, it is known the optimum value of the LEED. However, the same LEED may be obtained by varying the ratio between the laser power and the fiber pullback speed. Power decrease can allow to reduce the incidence of adverse effects of endovenous laser ablation, but keep high efficiency.

Conditions

  • Varicose Veins

Interventions

PROCEDURE

Endovenous laser ablation (EVLA)

Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber

DEVICE

Laser

Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

Sponsors & Collaborators

  • Medalp Private Surgery Clinic

    collaborator OTHER

  • Garantclinic

    collaborator OTHER

  • Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2021-05-19
Completion
2021-05-19

Countries

  • Russia

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 NCT03037827 on ClinicalTrials.gov