Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742932
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-02-15
Brief Title:
Study Evaluating the Performance and Safety of Global D Implants Indicated for Trauma Surgery CMF-TRAUMA
Sponsor:
Global D
Organization:
Global D
Study Overview
Official Title:
Prospective Study to Evaluate the Performance by the Assessment of Patients Mandibular Function and the Safety of Global Ds Implants of Cranio-maxillofacial Surgery Indicated for Trauma Surgery CMF-TRAUMA
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This study is set up within the framework of the European Union regulation 2017745 on medical devices Its objective is to confirm the performance and safety of the Global D implants ORTRAUTEK and MINITEKMICROTEK used for trauma surgery
Detailed Description:
Study design Non-interventional prospective multicentric national open-label non-comparative study
Investigators at least 6 sites in France
A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices
Investigators at least 6 sites in France
A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices
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