Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT04547959
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2020-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®
Sponsor:
Medicrea International
Organization:
Study Overview
Official Title:
Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®
Status:
COMPLETED
Status Verified Date:
2025-01
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:
C-CURVE
Brief Summary:
This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium.
The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine.
This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.
The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine.
This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.
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?:
False
Is an FDA AA801 Violation?: