Trials / Suspended
SuspendedNCT04950582
In Vitro Analysis of Human Urine With the CloudCath Device
- Status
- Suspended
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- CloudCath · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.
Detailed description
Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection. To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months. Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Spectral characteristics assessment | Urine sample analysis for evidence of urinary tract infection |
Timeline
- Start date
- 2021-06-04
- Primary completion
- 2024-06-15
- Completion
- 2024-06-15
- First posted
- 2021-07-06
- Last updated
- 2023-09-21
Locations
1 site across 1 country: Mexico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04950582. Inclusion in this directory is not an endorsement.