Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036758
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-09-07
Brief Title:
VIDAS NEPHROCLEAR Diagnostic Accuracy Study
Sponsor:
BioMérieux
Organization:
BioMérieux
Study Overview
Official Title:
VIDAS NEPHROCLEAR CCL14 Diagnostic Accuracy Study
Status:
COMPLETED
Status Verified Date:
2023-09
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:
This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury AKI will be tested in order to validate the VIDAS NEPHROCLEAR CCL14 Test
Detailed Description:
The VIDAS NEPHROCLEAR CCL14 Test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe stage 2 or 3 acute kidney injury AKI as an aid in the risk assessment for developing persistent severe AKI stage 3 AKI lasting 72 hours within 48 hours of patient assessment
The VIDAS NEPHROCLEAR CCL14 Test is intended to be used in patients 21 years of age or older
The objective of this study is to evaluate the diagnostic accuracy of the VIDAS NEPHROCLEAR CCL14 test when used on the VIDAS 3 instrument Sensitivity specificity negative predictive value NPV positive predictive value PPV likelihood ratios LR and relative risk RR will be evaluated at the pre-determined cut-off values
Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study The VIDAS test results will be compared to the clinical AKI status established by independent adjudication by medical professionals that are blinded to the VIDAS test results
The VIDAS NEPHROCLEAR CCL14 Test is intended to be used in patients 21 years of age or older
The objective of this study is to evaluate the diagnostic accuracy of the VIDAS NEPHROCLEAR CCL14 test when used on the VIDAS 3 instrument Sensitivity specificity negative predictive value NPV positive predictive value PPV likelihood ratios LR and relative risk RR will be evaluated at the pre-determined cut-off values
Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study The VIDAS test results will be compared to the clinical AKI status established by independent adjudication by medical professionals that are blinded to the VIDAS test results
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?:
False
Is an FDA AA801 Violation?:
None