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

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia203 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

203

Conditions

Varicose Veins

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 sec No prior treatment of the insufficient GSV Informed consent Exclusion Criteria: Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on the thigh Immobility Allergy to lidocaine Arterial insufficiency

Locations (2)

Clinic of Phlebology and Laser Surgery

Chelyabinsk, Russia

GarantClinic

Moscow, Russia

Outcomes

Primary Outcomes

The number of participants with a fully obliterated target vein

An ultrasound investigation of the treated vein to find out is the treated vein is fully obliterated or not, and to find out is there any pathological reflux in the vein.

Time frame: 3 month

Secondary Outcomes

Pain score

Pain (numeric rating scale)

Time frame: day 1

Pain score

Pain (numeric rating scale)

Time frame: day 7