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

NCT03856814 | Completed

• 1 other identifier: BM-VL-01 ZOL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

• To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.

  The participating investigators will register the incentives (based on clinical examination and/or anatomic outcome by duplex ultrasound, as well as secondary considerations) to use laser ablation or conventional treatment for varicose veins in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.

  At baseline

• To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.

  The participating investigators will re-evaluate the chosen treatment option and document this re-evaluation in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.

  At 6 weeks follow-up

Secondary Outcomes (18)

• Procedural characteristics

  At index-procedure

• Procedural characteristics

  At index-procedure

• Procedural characteristics

  At index-procedure

• Procedural characteristics

  At index-procedure

• Procedural characteristics

  At index-procedure

Study Arms (1)

Patients with varicose veins

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.

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

Interventions

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

Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

Patients with varicose veins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

500 patients with varicose veins, indicative for treatment with Endovenous laser ablation (EVLA) or Surgery (ligation/stripping) according to routine patient care.

You may qualify if:

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

You may not qualify if:

• Current deep vein thrombosis.
• Acute superficial thrombosis.
• Pregnancy.
• Coagulopathy or bleeding disorders.
• Contraindications to the use of general or regional anesthesia.

Sponsors & Collaborators

• Duomed: lead

Study Sites (1)

Ziekenhuis Oost-Limburg (Sint-Jan,Genk; Sint-Barbara,Lanaken; ZMK,Maaseik)

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 27, 2019
• Study Start: March 15, 2019
• Primary Completion: January 13, 2023
• Study Completion: November 8, 2023
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

BE (1)