In Vitro Analysis of Human Urine With the CloudCath Device

CloudCath

Status: Suspended

Conditions: Urinary Tract Infections

Treatments: Diagnostic Test: Spectral characteristics assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT04950582

CC-L-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

UTI-high risk patients

Description:

patients who are at high risk for developing a urinary tract infection (UTI).

Treatment:

Diagnostic Test: Spectral characteristics assessment