In Vitro Analysis of Human Urine With the CloudCath Device

Suspended

• Conditions: Urinary Tract Infections
• Interventions: Diagnostic Test: Spectral characteristics assessment

• Registration Number: NCT04950582
• Lead Sponsor: CloudCath

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.

Study Timeline

• Study Start: 2021-06-04
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-07-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UTI-high risk patients	Spectral characteristics assessment	patients who are at high risk for developing a urinary tract infection (UTI).

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

CloudCath Investigational Site; 🇲🇽 Guadalajara, Jalisco, Mexico