The Sapheon Closure System Feasibility Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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

1. demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,

2. demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and

3. demonstrate the satisfactory performance of the Sapheon™ Closure System device components. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01603433
Study type	Interventional
Source	Medtronic Endovascular
Contact
Status	Completed
Phase	N/A
Start date	July 2011
Completion date	July 2014

View Details

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