Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437990
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-31
First Post:
2024-05-26
Brief Title:
Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Surgery
Sponsor:
Siriraj Hospital
Organization:
Siriraj Hospital
Study Overview
Official Title:
Pilot Study of Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Injured Patients With Insufficient Flow of Donor Artery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
None
Brief Summary:
Free functional muscle transfer FFMT using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries Successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap However some brachial plexus injuries are accompanied by subclavian or axillary artery injuries which compromise the viability of the muscle flap due to insufficient vascular supply To address this arteriovenous AV loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions including the upper extremity Despite their widespread use AV loop grafts have not been previously utilized in FFMT for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries This study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None