Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 11:50 AM
Study NCT ID:
NCT03644251
Status:
TERMINATED
Last Update Posted:
2019-03-15
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FLO for Discogenic Pain
Sponsor:
BioTissue Holdings, Inc
Organization:
Study Overview
Official Title:
FLO Injection for Discogenic Pain
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study Site Ceased all Business Operations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.
Detailed Description:
None
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?: