In Vitro Analysis of Human Urine With the CloudCath Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-04

Study Completion Date

2024-06-15

Brief Summary

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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.

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Detailed Description

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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

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Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UTI-high risk patients

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

Spectral characteristics assessment

Intervention Type DIAGNOSTIC_TEST

Urine sample analysis for evidence of urinary tract infection

Interventions

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Spectral characteristics assessment

Urine sample analysis for evidence of urinary tract infection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No