Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05483088
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2022-07-29
Brief Title:
Urine Sample Processing Study
Sponsor:
Astute Medical Inc
Organization:
Astute Medical Inc
Study Overview
Official Title:
Urine Sample Processing Study Analysis of Fresh Versus Frozen Urine Samples From ICU Subjects
Status:
COMPLETED
Status Verified Date:
2023-10
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 objective of the study is to collect and process urine samples from Intensive Care Unit ICU subjects with moderate to severe Stage 2 or 3 acute kidney injury AKI for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR CCL14 Test results This study is observational and will have no impact on the medical management of the subject
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None