Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03940963
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2019-05-06
Brief Title:
Study of AxoGuard Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma Prevention of Recurrent Neuroma Pain
Sponsor:
Axogen Corporation
Organization:
Axogen Corporation
Study Overview
Official Title:
A Multicenter Prospective Randomized and Subject Blinded Comparative Study of AxoGuard Nerve Cap and Neurectomy for the Treatment of Symptomatic Neuroma and Prevention of Recurrent End-Neuroma Pain
Status:
COMPLETED
Status Verified Date:
2024-08
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
Brief Summary:
Comparing safety pain user experience healthcare economic costs work productivity impairment and quality of life outcomes between Axoguard Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot Study consists of a 15 subject pilot phase with Axoguard Nerve Cap implants followed for 3 months and then a comparative study of 86 subjects randomized between the treatment groups followed for 12 months
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