RecruitingNot ApplicableNCT06971068

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

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


Sponsor

Center Of Phlebology

Enrollment

184 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Procedure: EVLA and Procedure: VALA for people with varicose veins. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProcedure: EVLA

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

PROCEDUREProcedure: 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

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NCT06971068


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