In Vitro Analysis of Human Urine With the CloudCath Device | NCT04950582

Studies
In Vitro Analysis of Human Urine With the CloudCath Device

NCT04950582

Sponsor

CloudCath

Status

Suspended

Last Update Posted

Sep 21, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Urinary Tract Infections

Interventions

Spectral characteristics assessment

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

temporary pause due to business priorities

Expanded Access Info

Start Date

Jun 4, 2021Actual

Primary Completion Date

Jun 15, 2024Estimated

Completion Date

Jun 15, 2024Estimated

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 25, 2021

First Posted Date

Jul 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2023

Last Update Posted Date

Sep 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UTI-high risk patients		patients who are at high risk for developing a urinary tract infection (UTI).	Diagnostic Test: Spectral characteristics assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spectral characteristics assessment	Diagnostic Test	Urine sample analysis for evidence of urinary tract infection	UTI-high risk patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with indwelling urinary catheters

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ben Briggs, MD, PhD	University of California, San Francisco	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CloudCath Investigational Site		Guadalajara	Jalisco		Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided