Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494631
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Xeltis Hemodialysis Access Graft aXess US Study
Sponsor:
Xeltis
Organization:
Xeltis
Study Overview
Official Title:
Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
A multi-center prospective single-arm non-randomized staged pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above diagnosed with end-stage kidney disease and possessing an estimated glomerular filtration rate eGFR less than 20 mlmin who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None