Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-26 @ 9:59 PM
Study NCT ID:
NCT05073757
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2021-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study to Evaluate the Performance and Safety of Custom-made Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Sponsor:
Global D
Organization:
Study Overview
Official Title:
Prospective Study to Evaluate the Performance and Safety of Custom-made Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Status:
COMPLETED
Status Verified Date:
2025-07
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:
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
Our project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.
Our project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: