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RECRUITING
NCT06971068
NA

Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins

Sponsor: Center Of Phlebology

View on ClinicalTrials.gov

Summary

Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. However, there are controversial data concerning their efficacy and safety in ablating large saphenous veins because of high risk of heat-induced thrombosis (EHIT), incomplete ablation and recanalization.1-5 The use of vacuum evacuation of the remaining intraluminal blood during endovenous laser ablation allows to decrease the risk of intraoperative (carbonization and destruction of the fiber lens) and postoperative complications (EHIT, hyperpigmentation, "string" feeling) and leads to reduction of recovery because of short period of vein resorption. The aim of the study is to evaluate the safety and effectiveness of endovenous thermal ablation with or without vacuum evacuation for the treatment of incompetent large saphenous veins (\>15 mm).

Official title: Endovenous Vacuum-assisted Laser Ablation (VALA) in the Treatment of Large Saphenous Veins (> 15 mm)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2025-03-15

Completion Date

2026-02-15

Last Updated

2025-05-14

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Procedure: EVLA

Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring fiber

PROCEDURE

Procedure: VALA

Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring Pro fiber

Locations (9)

Clinic in Uruchye

Minsk, Belarus

Merci clinic

Minsk, Belarus

SANTE clinic

Minsk, Belarus

Center Of Phlebology

Bishkek, Chuy Region, Kyrgyzstan

Laser Surgery Center

Moscow, Russia

Innovative vascular centre

Saint Petersburg, Russia

Derzhavin Tambov State University

Tambov, Russia

Clinic of Modern Phlebology "VarikozOFF"

Tashkent, Uzbekistan

Clinic of Modern Phlebology "VarikozOFF"

Tashkent, Uzbekistan