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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
Urine sample analysis for evidence of urinary tract infection
CloudCath Investigational Site
Guadalajara, Jalisco, Mexico
Spectral characteristics of urine specimens
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).
Time frame: During the period of time that the patient is catheterized (expected to be up to ~1 week)
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