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| Name | Class |
|---|---|
| European Venous Forum. | UNKNOWN |
| Benelux Society of Phlebology. | OTHER |
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Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,…
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiofrequency ablation with VNUS closure fast | Active Comparator | Radiofrequency ablation will be performed with VNUS closure fast. |
|
| laser ablation and Tulip fiber | Experimental | Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulip fiber | Device | Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Closure of the greater saphenous vein at 12 months. | Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months. | 12 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 5 days |
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carend Randon, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium | |||
| University Hospital Leuven |
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| Label | URL |
|---|---|
| Related Info | View source |
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| VNUS closure fast | Device | Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'. |
|
| after 14 days |
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 1 month |
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 6 months |
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 1 year. |
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 5 days |
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 14 days. |
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 month |
| Pain satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 6 months |
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 year. |
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 5 days |
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 14 days |
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 month |
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 6 months |
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 year |
| Leuven |
| 3000 |
| Belgium |
| Sint-Andriesziekenhuis Tielt | Tielt | 8700 | Belgium |
| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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