An observational study in Varicose Veins, sponsored by Duomed. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Duomed · Observational
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).
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
This study's enrollment of 500 is above the median of 159 across 62 observational studies indexed under Varicose Veins.
Browse Varicose Veins studies →Duomed is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
500 patients with varicose veins, indicative for treatment with Endovenous laser ablation (EVLA) or Surgery (ligation/stripping) according to routine patient care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: At 6 weeks follow-up
Procedural characteristics
Type of anesthesia
Time frame: At index-procedure
Procedural characteristics
Number, type and length of veins treated
Time frame: At index-procedure
Procedural characteristics
Total energy per patient and fiber (when using the ELVeS® Radial® 2ring slim fiber)
Time frame: At index-procedure
Procedural characteristics
Number of procedures showing technical success, defined as the ability to treat the varicose veins as planned
Time frame: At index-procedure
Procedural characteristics
Peri-operative adverse events (bleeding, incomplete treatment, technical defects, difficult visualization, ...)
Time frame: At index-procedure
Procedural characteristics
Duration of the index-procedure
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 6 months follow-up
Re-interventions
Number of participants with re-interventions
Time frame: At discharge, up to 1 week
Re-interventions
Number of participants with re-interventions
Time frame: At 6 weeks follow-up
Re-interventions
Number of participants with re-interventions
Time frame: At 6 months follow-up
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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