Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT02119832
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
Sponsor:
C. R. Bard
Organization:
Study Overview
Official Title:
A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction
Status:
COMPLETED
Status Verified Date:
2025-11
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:
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: