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

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856814
• Other study ID #: BM-VL-01
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: Duomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 8, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Varicose Veins

Intervention

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg (Sint-Jan,Genk; Sint-Barbara,Lanaken; ZMK,Maaseik)	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Procedural characteristics	Type of anesthesia	At index-procedure
Secondary	Procedural characteristics	Number, type and length of veins treated	At index-procedure
Secondary	Procedural characteristics	Total energy per patient and fiber (when using the ELVeS® Radial® 2ring slim fiber)	At index-procedure
Secondary	Procedural characteristics	Number of procedures showing technical success, defined as the ability to treat the varicose veins as planned	At index-procedure
Secondary	Procedural characteristics	Peri-operative adverse events (bleeding, incomplete treatment, technical defects, difficult visualization, …)	At index-procedure
Secondary	Procedural characteristics	Duration of the index-procedure	At index-procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Re-interventions	Number of participants with re-interventions	At discharge, up to 1 week
Secondary	Re-interventions	Number of participants with re-interventions	At 6 weeks follow-up
Secondary	Re-interventions	Number of participants with re-interventions	At 6 months follow-up