Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 7:55 PM
Study NCT ID:
NCT06010433
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2023-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CERAMENT G Device Registry
Sponsor:
BONESUPPORT AB
Organization:
Study Overview
Official Title:
CERAMENT G Device Registry
Status:
RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
This is an Observational Device Registry Study of CERAMENT\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: