Study of Vacuum-assisted Laser Ablation for Treating Large Varicose Veins in the Legs Evaluating Safety and Effectiveness of Two Laser Techniques for Large Saphenous Veins

What this Trial Is About

Researchers are evaluating the safety and effectiveness of endovenous thermal ablation treatments for large saphenous veins larger than 15 mm in diameter, which cause varicose veins in the lower limbs. This study focuses on comparing two methods one using a standard laser fiber and another using a laser fiber with vacuum evacuation to reduce complications and improve recovery. The goal is to better understand which approach is safer and more effective in treating symptomatic vein reflux. Participants receive endovenous laser ablation using either the ELVeS Radial 2ring fiber or the ELVeS Radial 2ring Pro fiber. The Pro fiber is connected to a vacuum suction during the procedure to remove remaining blood from the vein and potentially lower risks like heat-induced thrombosis. Before treatment, patients are examined with ultrasound to measure vein diameters, and the energy used for laser ablation is calculated based on these measurements. Compression stockings are worn after the procedure to support recovery. During the study, participants will be monitored at multiple time points one day, two weeks, one month, three months, and six months after treatment. Researchers will assess vein occlusion, pain levels, clinical status, severity of chronic venous disease, quality of life, and any side effects like hyperpigmentation or adverse events. Histological analysis of the treated veins will also be performed at selected times. This follow-up helps track how well each treatment works and the participants overall health during recovery.

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