Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616025
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
This Study Will Evaluate the Effectiveness of NTX-001 a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 3 Multicenter Randomized Subject and Evaluator Blinded Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care Neurorrhaphy in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80
Detailed Description:
NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves It often takes months andor years to determine if function will be restored By that point restoration is often incomplete and can result in lifelong motor andor sensory deficits By reconnecting PEG-fusion a substantial number of axons within a severed nerve the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets respectively NTX-001 PEG-fusion has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None