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A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis | Clinical Trials | Clareo Health

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A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis

A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis

NCT04515498•CloudCath

View on ClinicalTrials.gov

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.

Detailed Description

This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care. Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The notification capability of the CloudCath System will be deactivated for this study so that neither Study Participants nor Study Investigators will be aware of the device measurements. Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

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

Locations (1)

CloudCath Investigational Site

Lakewood, Colorado, United States

Key Dates

Start Date

August 19, 2020

Primary Completion Date

March 31, 2023

Completion Date

March 31, 2023

Last Updated

May 30, 2023

Enrollment

243

ACTUAL participants

Conditions

Peritoneal Dialysis-associated Peritonitis

Interventions

CloudCath Monitoring System

DEVICE

Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis

NCT05971537

Peritoneal Dialysis-associated Peritonitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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