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Evaluation of the Safety and Performance of the Neocement®
Sponsor: Bioceramed
Summary
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.
Official title: Evaluation of the Safety and Performance of the Neocement®: A Prospective Observational Study in Orthopaedic Area
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2025-09-05
Completion Date
2027-06
Last Updated
2026-02-04
Healthy Volunteers
No
Locations (1)
Unidade Local de Saúde Esposende/Barcelos
Barcelos, Portugal