NCT01603433

The Sapheon Closure System Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 21 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Venous Insufficiency of Leg

Interventions

Type	Name	Description
DEVICE	Sapheon™ Closure System	Sapheon™ Closure System for the treatment of incompetent saphenous veins.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-07-01
• Completion: 2014-07-01
• First posted: 2012-05-22
• Last updated: 2016-05-03

Locations

1 site across 1 country: Dominican Republic