Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-02-11 @ 11:23 AM
Study NCT ID:
NCT05119595
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
Sponsor:
Aesculap AG
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRANFLAP
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: