The Sapheon Closure System Feasibility Study
This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.
Venous Insufficiency of Leg
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Sapheon Closure System Feasibility Study|
- Anatomical Success [ Time Frame: 30 days post procedure ] [ Designated as safety issue: No ]Evaluation of anatomic efficacy will be demonstrated by the absence of flow (Complete Closure) within the treated vein segment as determined by duplex ultrasound examination and will be performed in accordance with a standardized and detailed imaging protocol.
- Safety Endpoint [ Time Frame: Through 6 month follow-up ] [ Designated as safety issue: Yes ]Evaluation of safety will be assessed by the DSMB of all incidence of adverse events (procedure and non-procedure related; serious and non-serious)
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. The primary objectives for this clinical Study are to
- demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,
- demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and
- demonstrate the satisfactory performance of the Sapheon™ Closure System device components.