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| Name | Class |
|---|---|
| Biolitec Pharma Ltd. | INDUSTRY |
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This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with varicose veins, eligible for EVLA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELVeS® Radial® 2ring slim fiber | Device | Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anatomic success | defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography | at 1 month follow-up |
| Anatomic success | defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography | at 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural characteristics | Details concerning 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. |
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Inclusion Criteria:
Exclusion Criteria:
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150 patients with varicose veins, eligible for treatment with EndoVenous Laser Ablation (EVLA).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Hospital | Bonheiden | Antwerp | 2820 | Belgium | ||
| Jessa Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37545129 | Derived | Verbist J, Laeremans V, Gryffroy F, Van den Eynde W, Heerinckx C, Haesen D. Durability and efficacy of the ELVeS(R) Radial(R) 2ring slim fiber for multiple ablations. Phlebology. 2023 Dec;38(10):641-648. doi: 10.1177/02683555231193883. Epub 2023 Aug 6. |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| discharge |
| 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 1 week follow-up |
| Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS) | The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3. | at 1 month follow-up |
| Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS) | The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3. | at 12 months follow-up |
| Post-operative adverse events | numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. | at 1 week follow-up |
| Post-operative adverse events | numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. | at 1 month follow-up |
| Post-operative adverse events | numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. | at 12 months follow-up |
| Re-interventions | including reason for re-intervention and description of treatment | at 1 week follow-up |
| Re-interventions | including reason for re-intervention and description of treatment | at 1 month follow-up |
| Re-interventions | including reason for re-intervention and description of treatment | at 12 months follow-up |
| Hasselt |
| Limburg |
| 3500 |
| Belgium |