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Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)
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/MICROTEK®) used for trauma surgery.
Key Details
Gender
All
Age Range
11 Years - Any
Study Type
OBSERVATIONAL
Enrollment
102
Start Date
2023-03-07
Completion Date
2026-08
Last Updated
2026-01-14
Healthy Volunteers
No
Interventions
Trauma surgery using Global D's implants.
Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).
Locations (2)
Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)
Lyon, France
Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)
Lyon, France