Trials / Completed
CompletedNCT05483088
Urine Sample Processing Study
Urine Sample Processing Study: Analysis of Fresh Versus Frozen Urine Samples From ICU Subjects
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (actual)
- Sponsor
- Astute Medical, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Urine collection for NEPHROCLEAR CCL14 Test | Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test |
Timeline
- Start date
- 2021-11-12
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
- First posted
- 2022-08-01
- Last updated
- 2023-10-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05483088. Inclusion in this directory is not an endorsement.