In Vitro Analysis of Human Urine With the CloudCath Device

NCT04950582 | Suspended FDA Device

• 1 other identifier: CC-L-008
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

UTI-high risk patients

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

Diagnostic Test: Spectral characteristics assessment

Interventions

Spectral characteristics assessment DIAGNOSTIC_TEST

Urine sample analysis for evidence of urinary tract infection

UTI-high risk patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with indwelling urinary catheters

You may qualify if:

• provide a signed informed consent
• patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)

You may not qualify if:

• 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

Sponsors & Collaborators

• CloudCath: lead

Study Sites (1)

CloudCath Investigational Site

Guadalajara, Jalisco, Mexico

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ben Briggs, MD, PhD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 6, 2021
• Study Start: June 4, 2021
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)