Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05971329
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-07-18
Brief Title:
Pilot Study of ZetaFuse Bone Graft for the Treatment of Cervical Degenerative Disc Disease
Sponsor:
Zetagen Therapeutics Inc
Organization:
Zetagen Therapeutics Inc
Study Overview
Official Title:
Pilot Study of ZetaFuse Bone Graft for the Treatment of Cervical Degenerative Disc Disease
Status:
RECRUITING
Status Verified Date:
2024-07
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 goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function
Participants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function
Participants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function
Detailed Description:
The indication under investigation is for use in the skeletally mature patients for fusion of two contiguous vertebral bodies in the cervical spine from C3-C7 following discectomy for intractable radiculopathy with or without neck pain or myelopathy due to abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imagingherniated nucleus pulposus spondylosis defined by the presence of osteophytes andor visible loss of disc height as compared to adjacent levels
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