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

NCT06971068 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-05-14

No results posted yet for this study

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).

Conditions

  • Varicose Veins

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

Sponsors & Collaborators

  • Center Of Phlebology

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2025-09-15
Completion
2026-02-15

Countries

  • Belarus
  • Kyrgyzstan
  • Russia
  • Uzbekistan

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 NCT06971068 on ClinicalTrials.gov