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

CloudCath

Status: Completed

Conditions: Peritoneal Dialysis-associated Peritonitis

Treatments: Device: CloudCath Monitoring System

Study type: Observational

Funder types: Industry

Identifiers

NCT04515498

CC-P-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

243 participants in 1 patient group

CloudCath System

Description:

Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis

Treatment:

Device: CloudCath Monitoring System