Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
NCT05271383 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 198
Last updated 2026-01-14
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.
Conditions
- Orthognathic Surgery
- Maxillofacial Abnormalities
- Maxilla Fracture
Interventions
- DEVICE
-
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).
Sponsors & Collaborators
-
Global D
lead INDUSTRY
Principal Investigators
-
Pierre CORRE, MD · Cranio-maxillofacial surgeon
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-04
- Primary Completion
- 2024-08-02
- Completion
- 2024-08-02
Countries
- France
Study Locations
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