Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?

BE Medical

Status: Completed

Conditions: Varicose Veins

Treatments: Device: ELVeS® Radial® 2ring slim fiber

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03810677

ELVeS-01

Details and patient eligibility

About

This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.

Enrollment: 150 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 symptomatic varicose veins (CEAP grade ≥ C2).
4. Patient has an insufficient Great Saphenous Vein (GSV), with or without laser ablation of anterior accessory saphenous vein (AASV), posterior accessory saphenous vein (PASV), and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence), suitable for endovenous laser ablation (EVLA).
5. Maximum diameter of the to be treated veins is ≤ 14mm.

Exclusion criteria

1. Current deep vein thrombosis.
2. Acute superficial thrombosis.
3. Mean diameter of the to be treated veins > 14mm.
4. Tortuous or very superficial veins considered unsuitable for laser treatment.
5. Recurrent varicose veins.
6. Pregnancy.
7. Coagulopathy or bleeding disorders.
8. Contraindications to the use of general or regional anesthesia.

Trial design

150 participants in 1 patient group

Patients with varicose veins, eligible for EVLA

Treatment:

Device: ELVeS® Radial® 2ring slim fiber