Recruiting

Observational StudyA Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis

Sponsor:

CloudCath

Code:

NCT05285436

Conditions

End Stage Renal Disease

Peritoneal Dialysis-associated Peritonitis

Peritonitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CloudCath System

Study Details

Brief summary:

This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.

Conditions

End Stage Renal Disease

Peritoneal Dialysis-associated Peritonitis

Peritonitis

Study ID

NCT05285436

Start date

Mar 16, 2022

Status verified date

Sep, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

currently using peritoneal dialysis
provides informed consent
willing to comply with the requirements of the study
has cellular data coverage at home

Key Exclusion Criteria:

active or history of cancer requiring chemotherapy within prior 6 months
signs or symptoms of an active infection within 14 days prior to enrollment
peritonitis diagnosis within 30 days prior to enrollment
participating in another investigational device or drug study that may potentially affect study results
other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study

Study Design

Enrollment

314 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CloudCath detection

Active monitoring of dialysate effluent by the CloudCath System.

Interventions

CloudCath System

The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.

Primary outcome measure

Time to peritonitis diagnosis [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Brian Fisher

+1 (415) 651-3393 brian@cloudcath.com

Concetta Carbonaro

concetta@cloudcath.com

Locations

Dialysis Center of Western Massachusetts Llc

Recruiting

Chicopee, Massachusetts, United States, 01020

More Information

Sponsor

CloudCath

Last update posted

Sep 21, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CloudCath on 2023-09-21.