Early Outcome of Mechanochemical Endovenous Ablation (ClariVein-2)
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study|
- Occlusion rate [ Time Frame: 30 days, 1, 2, and 5 years ]The percentage of GSV occluded
- Health status [ Time Frame: 30 days, 1, 2, and 5 years ]
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.
- Disease related quality of life [ Time Frame: 30 days, 1, 2, and 5 years ]Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.
- Pain score during procedure [ Time Frame: peri-procedural ]The pain will be scored during procedure using the VAS score.
- 2-weeks post-procedure pain score [ Time Frame: two weeks ]The pain will be scored daily for two weeks after the procedure using the VAS score.
- recovery time [ Time Frame: two weeks ]The time (in days) after the procedure until patients were able to restart daily activity/daily work
- procedural complications [ Time Frame: during procedure ]all complications related to the procedure will be evaluated at the mentioned time points.
- post-procedural complications [ Time Frame: 1 year ]all complications related to the procedure will be evaluated at the mentioned time points.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Patients with insufficiency of the greater saphenous vein (GSV) will be included.
Using the ClariVein device, the GSV will be occluded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459263
|Arnhem, Gelderland, Netherlands|
|St. Antonius Hospital|
|Principal Investigator:||Michel MJ Reijnen, MD, PhD||Rijnstate Hospital|
|Principal Investigator:||Jean-Paul Vries, de, MD, Phd||St. Antonius Hospital|