Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865679
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-04-22
Brief Title:
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Sponsor:
Axogen Corporation
Organization:
Axogen Corporation
Study Overview
Official Title:
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Status:
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:
REPOSE-XL
Brief Summary:
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap sizes 5-7 mm for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP-OR180222 | OTHER_GRANT | Department of Defense | None |