Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415136
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-17
First Post:
2024-05-10
Brief Title:
Adjacent Level Anterior Cervical Fusion SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
Sponsor:
Research Source
Organization:
Research Source
Study Overview
Official Title:
Adjacent Level Anterior Cervical Fusion SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine
Detailed Description:
This is a retrospective prospective post-market observational single-center single surgeon study evaluating the use of the SeaSpine Shoreline device Patients will be identified by the Investigator as needing or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria
Study Oversight
Has Oversight DMC:
None
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?:
None