Ignite Creation Date:
2024-05-06 @ 2:45 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02119832
Status:
COMPLETED
Last Update Posted:
2014-04-22
First Post:
2014-04-17
Brief Title:
A Prospective Clinical Evaluation of the Total Vascular Access TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction IR
Sponsor:
TVA Medical Inc
Organization:
TVA Medical Inc
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:
2014-04
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:
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:
None
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?:
None