Trials / Completed
CompletedNCT05119595
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
Prospective, Single Center PMCF-study on the Performance and Safety of the CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures to the Neurocranium
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer. The aim of this observational study is to collect systematically and proactively data regarding the performance of CranioFix®2, like adverse events (AEs), handling and cosmetic outcome, under daily clinical practice when used as intended by the manufacturer.
Conditions
Timeline
- Start date
- 2022-03-22
- Primary completion
- 2023-03-09
- Completion
- 2023-10-27
- First posted
- 2021-11-15
- Last updated
- 2025-05-13
- Results posted
- 2025-05-13
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05119595. Inclusion in this directory is not an endorsement.