Market Penetration of Laser Therapy in Venous Surgery: Ziekenhuis Oost-Limburg - Ziekenhuis Maas En Kempen Center Experience

Duomed

Status: Completed

Conditions: Varicose Veins

Treatments: Device: ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT03856814

BM-VL-01 ZOL

Details and patient eligibility

About

The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is at least 18 years old.
2. Patient must sign and date the informed consent form prior to treatment.
3. Presence of unilateral or bilateral primary or recurrent symptomatic varicose veins (CEAP grade ≥ C2).
4. Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).

Exclusion criteria

1. Current deep vein thrombosis.
2. Acute superficial thrombosis.
3. Pregnancy.
4. Coagulopathy or bleeding disorders.
5. Contraindications to the use of general or regional anesthesia.

Trial design

500 participants in 1 patient group

Patients with varicose veins

Description:

Patients with varicose veins, indicative for treatment with EndoVenous Laser Ablation (EVLA) using the ELVeS® Radial® 2ring slim fiber or Surgery (ligation/stripping) according to the standard of care of the participating investigators.

Treatment:

Device: ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation