Urinary Tract Infections
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTSpectral characteristics assessment
Urine sample analysis for evidence of urinary tract infection
Sponsors
CloudCath
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* provide a signed informed consent * patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)
Exclusion criteria
* any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study * currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI) * suprapubic bladder catheter implanted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spectral characteristics of urine specimens | During the period of time that the patient is catheterized (expected to be up to ~1 week) | A quantitative analysis of the spectral properties of the urine specimen using a proprietary algorithm that results in a quantitative CloudCath Turbidity Score (0-100, with higher values indicating more turbidity). |
Countries
Mexico
Outcome results
None listed