Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 6:09 PM
Study NCT ID:
NCT01603433
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2012-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sapheon Closure System Feasibility Study
Sponsor:
Medtronic Endovascular
Organization:
Study Overview
Official Title:
The Sapheon Closure System Feasibility Study
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: