Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-07 @ 10:18 PM
Study NCT ID:
NCT03943134
Status:
TERMINATED
Last Update Posted:
2025-08-20
First Post:
2019-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity
Sponsor:
Axogen Corporation
Organization:
Study Overview
Official Title:
A Multicenter, Ambispective, Clinical Outcomes Registry Study of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity
Status:
TERMINATED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Axogen suspended market availability of the Avive® Soft Tissue Membrane effective June 1, 2021. This decision was not related to any safety concerns or product quality issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSIST
Brief Summary:
A registry study to evaluate the role of Avive® Soft Tissue Membrane in the management of nerve injury associated with acute trauma in the upper extremity.
Detailed Description:
This is a multicenter outcomes registry study of Avive® Soft Tissue Membrane in the management of nerve injuries associated with selected upper extremity acute trauma. The study will evaluate clinical condition, economic impact, and functional outcomes.
Study Oversight
Has Oversight DMC:
False
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?: