Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-04 @ 7:56 PM
Study NCT ID:
NCT04171960
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the i-STAT TBI Test
Sponsor:
Abbott Point of Care
Organization:
Study Overview
Official Title:
Clinical Evaluation of the i-STAT TBI Test
Status:
COMPLETED
Status Verified Date:
2024-09
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 study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).
Patients will be asked to provide a blood sample.
Patients will be asked to provide a blood sample.
Detailed Description:
The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a computed tomography (CT) scan in patients presenting with suspected mild traumatic brain injury (TBI) who are 18 years of age or older.
The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.
The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: