Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880537
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-03-01
Brief Title:
Decellularized Femoral Artery Allograft Nexeon AVX Prospective Registry
Sponsor:
LifeNet Health
Organization:
LifeNet Health
Study Overview
Official Title:
Safety Efficacy Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis A Multi-center Prospective Registry Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft Nexeon AVX Decellularized Femoral Artery
Detailed Description:
The clinical objective of this prospective observational post market registry study CR-21-005 is to assess the safety and efficacy of a decellularized human femoral artery allograft Nexeon AVX Decellularized Femoral Artery LifeNet Health Virginia Beach VA in the creation of vascular access for hemodialysis in patients with ESRD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None