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| Name | Class |
|---|---|
| St. Antonius Hospital | OTHER |
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More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSV insufficiency | Patients with insufficiency of the greater saphenous vein (GSV) will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClariVein | Device | Using the ClariVein device, the GSV will be occluded. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion rate | The percentage of GSV occluded | 30 days, 1, 2, and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Health status | Using the RAND 36-Item Short Form Health Survey (SF-36)the general health status will be evaluated at the mentioned time points. The SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. | 30 days, 1, 2, and 5 years |
| Disease related quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with insufficiency of the greater saphenous vein will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Michel MJ Reijnen, MD, PhD | Rijnstate Hospital | Principal Investigator |
| Jean-Paul Vries, de, MD, Phd | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | Netherlands | |||
| St. Antonius Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21679070 | Result | van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1. | |
| 21854655 | Result | van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch. |
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Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points. |
| 30 days, 1, 2, and 5 years |
| Pain score during procedure | The pain will be scored during procedure using the VAS score. | peri-procedural |
| 2-weeks post-procedure pain score | The pain will be scored daily for two weeks after the procedure using the VAS score. | two weeks |
| recovery time | The time (in days) after the procedure until patients were able to restart daily activity/daily work | two weeks |
| procedural complications | all complications related to the procedure will be evaluated at the mentioned time points. | during procedure |
| post-procedural complications | all complications related to the procedure will be evaluated at the mentioned time points. | 1 year |
| Nieuwegein |
| Netherlands |
| 23141679 | Result | van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8. |
| 23312507 | Result | Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9. |