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

Market Penetration of Laser Therapy in Venous Surgery: ZOL - ZMK Center Experience

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).

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Device: ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg (Sint-Jan,Genk; Sint-Barbara,Lanaken; ZMK,Maaseik)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural characteristics	Type of anesthesia	At index-procedure
Procedural characteristics	Number, type and length of veins treated	At index-procedure
Procedural characteristics	Total energy per patient and fiber (when using the ELVeS® Radial® 2ring slim fiber)	At index-procedure
Procedural characteristics	Number of procedures showing technical success, defined as the ability to treat the varicose veins as planned	At index-procedure
Procedural characteristics	Peri-operative adverse events (bleeding, incomplete treatment, technical defects, difficult visualization, …)	At index-procedure
Procedural characteristics	Duration of the index-procedure	At index-procedure
Pain scoring using the Visual Analog Scale (VAS)	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.	At discharge, up to 1 week
Pain scoring using the Visual Analog Scale (VAS)	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.	At 6 weeks follow-up
Anatomic success of EndoVenous Laser Ablation (EVLA)	Defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography.	At 6 weeks follow-up
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)	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.	At baseline
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)	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.	At 6 weeks follow-up
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)	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.	At 6 months follow-up
Post-operative adverse events	Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	At discharge, up to 1 week
Post-operative adverse events	Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	At 6 weeks follow-up
Post-operative adverse events	Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	At 6 months follow-up
Re-interventions	Number of participants with re-interventions	At discharge, up to 1 week
Re-interventions	Number of participants with re-interventions	At 6 weeks follow-up
Re-interventions	Number of participants with re-interventions	At 6 months follow-up

Collaborators and Investigators

• Sponsor: Duomed

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: BM-VL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No