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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)

NCT05742932 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Trauma Injury
  • Maxilla Fracture
  • Maxillofacial Trauma

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Global D

    lead INDUSTRY

Principal Investigators

  • Julie Chauvel-Picard, MD · Cranio-maxillofacial surgeon

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05742932 on ClinicalTrials.gov