clinical trial · NCT05742932
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
Global D·—·completed·n = 99
Trauma InjuryMaxilla FractureMaxillofacial TraumaTrauma surgery using Global D's implants.
brief summary
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for trauma surgery.
started
Mar 7, 2023
primary completion
Jun 2, 2026
completion
Jun 2, 2026
last updated
Sep 29, 2026
detailed description
Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.
Investigators : 5 sites in France.
A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol