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Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
Sponsor: Global D
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
198
Start Date
2022-02-04
Completion Date
2024-08-02
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Orthognathic surgery using Global D's implants.
Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s).
Locations (1)
CHU de Nantes
Nantes, France