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Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery — CMF-ORTHO  

Orthognathic Surgery Clinical Trial

Official title:
Prospective Study to Evaluate the Performance (by the Assessment of Patient's Quality of Life) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Orthognathic Surgery

Clinical Trial 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®) used for orthognathic surgery.

Clinical Trial Description

Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study. Investigators : 7 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05271383
Study type Observational [Patient Registry]
Source Global D
Contact
Status Active, not recruiting
Phase
Start date February 4, 2022
Completion date January 2025
View Details
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