In Vitro Analysis of Human Urine With the CloudCath Device

Urinary Tract Infections Clinical Trial

Official title:

In Vitro Analysis of Human Urine With the CloudCath Device

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04950582
• Other study ID #: CC-L-008
• Status: Suspended
• Start date: June 4, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: September 2023
• Source: CloudCath
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Diagnostic Test:
• Spectral characteristics assessment
Urine sample analysis for evidence of urinary tract infection

Locations

Country	Name	City	State
Mexico	CloudCath Investigational Site	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
CloudCath

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	During the period of time that the patient is catheterized (expected to be up to ~1 week)