RECRUITING

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

Conditions

End Stage Renal Disease Peritoneal Dialysis-associated Peritonitis Peritonitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using In-Home Peritoneal Dialysis

Quick Facts

Study Start:2022-03-16

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05285436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Study Contact

Brian Fisher

CONTACT

+1 (415) 651-3393

brian@cloudcath.com

Concetta Carbonaro

CONTACT

concetta@cloudcath.com

Principal Investigator

Glenn Chertow, MD

STUDY_DIRECTOR

Stanford University

Study Locations (Sites)

Dialysis Center of Western Massachusetts Llc

Chicopee, Massachusetts, 01020

United States

Collaborators and Investigators

Sponsor: CloudCath

Glenn Chertow, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-16

Study Completion Date2024-12

Study Record Updates

Study Start Date2022-03-16

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

End Stage Renal Disease
Peritoneal Dialysis-associated Peritonitis
Peritonitis