Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03060109
Status:
TERMINATED
Last Update Posted:
2017-10-02
First Post:
2017-02-17
Brief Title:
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System
Sponsor:
Banyan Biomarkers Inc
Organization:
Banyan Biomarkers Inc
Study Overview
Official Title:
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System FIRST DOWN
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Diagnostic platform no longer under development study termination not related to any safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRST DOWN
Brief Summary:
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury Glasgow Coma Scale score 13-15 from subjects over the age of 18 to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform
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?:
None