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

Completed

• Conditions: Varicose Veins
• Interventions: Device: ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation

• Registration Number: NCT03856814
• Lead Sponsor: Duomed

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-27
• Study Start: 2019-03-15
• Primary Completion: 2023-01-13
• Status Verified: 2023-11
• Study Completion: 2023-11-08
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with varicose veins	ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation	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.

Primary Outcome Measures

Name	Time	Method
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.	At 6 weeks follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Procedural characteristics	At index-procedure	Duration of the index-procedure
Pain scoring using the Visual Analog Scale (VAS)	At 6 weeks follow-up	The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
Anatomic success of EndoVenous Laser Ablation (EVLA)	At 6 weeks follow-up	Defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography.
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)	At 6 months follow-up	Aberdeen Varicose Vein Questionnaire (AVVQ) is a validated tool for assessing the perceived health of patients with varicose veins. The AVVQ comprises 13 quality of life questions, including a set of manikin legs, on which participants are asked to draw their veins.
Post-operative adverse events	At 6 months follow-up	Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Re-interventions	At 6 months follow-up	Number of participants with re-interventions

Trial Locations

Locations (1)

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