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NCT Number: NCT03856814

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

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: At baseline

    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.

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

    Time frame: 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 outcomes

  1. Procedural characteristics

    Time frame: At index-procedure

    Type of anesthesia

  2. Procedural characteristics

    Time frame: At index-procedure

    Number, type and length of veins treated

  3. Procedural characteristics

    Time frame: At index-procedure

    Total energy per patient and fiber (when using the ELVeS® Radial® 2ring slim fiber)

  4. Procedural characteristics

    Time frame: At index-procedure

    Number of procedures showing technical success, defined as the ability to treat the varicose veins as planned

  5. Procedural characteristics

    Time frame: At index-procedure

    Peri-operative adverse events (bleeding, incomplete treatment, technical defects, difficult visualization, …)

  6. Procedural characteristics

    Time frame: At index-procedure

    Duration of the index-procedure

  7. Pain scoring using the Visual Analog Scale (VAS)

    Time frame: At discharge, up to 1 week

    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.

  8. Pain scoring using the Visual Analog Scale (VAS)

    Time frame: 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.

  9. Anatomic success of EndoVenous Laser Ablation (EVLA)

    Time frame: At 6 weeks follow-up

    Defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography.

  10. Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: At baseline

    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.

  11. Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: At 6 weeks 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.

  12. Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: 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.

  13. Post-operative adverse events

    Time frame: At discharge, up to 1 week

    Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.

  14. Post-operative adverse events

    Time frame: At 6 weeks follow-up

    Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.

  15. Post-operative adverse events

    Time frame: At 6 months follow-up

    Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.

  16. Re-interventions

    Time frame: At discharge, up to 1 week

    Number of participants with re-interventions

  17. Re-interventions

    Time frame: At 6 weeks follow-up

    Number of participants with re-interventions

  18. Re-interventions

    Time frame: At 6 months follow-up

    Number of participants with re-interventions

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2019
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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