Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117501
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-10-27
Brief Title:
Nerve Protection Evaluation Revision Cubital Tunnel Syndrome Decompression
Sponsor:
Axogen Corporation
Organization:
Axogen Corporation
Study Overview
Official Title:
Nerve Protection Evaluation Revision Cubital Tunnel Syndrome Decompression
Status:
RECRUITING
Status Verified Date:
2024-09
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:
COVERED
Brief Summary:
This single-cohort prospective case series is designed to evaluate and characterize the use of Axoguard HA Nerve Protector to protect the ulnar nerve in a first revision cubital tunnel decompression procedure Data on the primary cubital tunnel syndrome decompression first revision decompression utilizing Axoguard HA Nerve Protector participant-reported pain motor and sensory functional outcomes quality of life QoL outcomes and recurrencerevision will be collected This case series will help to establish the ability of Axoguard HA Nerve Protector to provide clinical benefits for patients undergoing a first revision cubital tunnel decompression procedure
Detailed Description:
The objectives of this study are
1 To evaluate the use and characterize the performance of Axoguard HA Nerve Protector to protect the ulnar nerve in a first revision cubital tunnel decompression by understanding post-operative outcomes pain level QoL PROMs and ulnar nerve specific functional outcomes compared to baseline pre-revision operative levels
2 To summarize the safety of Axoguard HA Nerve Protector an FDA-cleared device in first revision cubital tunnel decompression procedures
3 To characterize the feasibility of Axoguard HA Nerve Protector to prevent the recurrence of compressive neuropathy of the ulnar nerve at the elbow and resulting need for future revision procedures
4 To characterize the feasibility of imaging the ulnar nerve pre- and post-operatively to assess nerve and tissue bed health
The study population includes participants 18 years of age or older presenting for evaluation of surgery for compressive ulnar nerve neuropathy at the elbow following a primary cubital tunnel syndrome decompression
Data will be collected from available medical records and patient reported outcomes questionnaires using approved data collection forms paper or electronic The following data will be collected at the respective study visits demographics primary decompression details revision decompression details baseline assessments health-related QoL questionnaires functional assessments and recovery assessments
There will be a total of nine 9 study visits Pre-op ScreeningBaseline and Operative Day visits plus seven 7 study follow-up events
1 To evaluate the use and characterize the performance of Axoguard HA Nerve Protector to protect the ulnar nerve in a first revision cubital tunnel decompression by understanding post-operative outcomes pain level QoL PROMs and ulnar nerve specific functional outcomes compared to baseline pre-revision operative levels
2 To summarize the safety of Axoguard HA Nerve Protector an FDA-cleared device in first revision cubital tunnel decompression procedures
3 To characterize the feasibility of Axoguard HA Nerve Protector to prevent the recurrence of compressive neuropathy of the ulnar nerve at the elbow and resulting need for future revision procedures
4 To characterize the feasibility of imaging the ulnar nerve pre- and post-operatively to assess nerve and tissue bed health
The study population includes participants 18 years of age or older presenting for evaluation of surgery for compressive ulnar nerve neuropathy at the elbow following a primary cubital tunnel syndrome decompression
Data will be collected from available medical records and patient reported outcomes questionnaires using approved data collection forms paper or electronic The following data will be collected at the respective study visits demographics primary decompression details revision decompression details baseline assessments health-related QoL questionnaires functional assessments and recovery assessments
There will be a total of nine 9 study visits Pre-op ScreeningBaseline and Operative Day visits plus seven 7 study follow-up events
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