Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05035693
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2021-03-12
Brief Title:
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE-C
Sponsor:
NGMedical GmbH
Organization:
NGMedical GmbH
Study Overview
Official Title:
PMCF MOVE-C International Prospective Multicentre Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics
Status:
RECRUITING
Status Verified Date:
2023-03
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:
PMCF_MOVE-C
Brief Summary:
Study design International prospective multicentre non-randomised observational study according to 23b MPG
Objectives Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE-C
Objectives Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE-C
Detailed Description:
This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE-C and to demonstrate the safety and performance Besides it is aimed to gain knowledge concerning the development of patients quality of life QoL after the implantation of the Cervical Disc Prosthesis MOVE-C and to collect data for the analysis of the range of motion ROM which is an essential parameter for motion-preserving implants
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DRKS00022971 | OTHER | Deutsches Register Klinischer Studien | None |