NCT04515498

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 243 (actual)
• Sponsor: CloudCath · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peritoneal Dialysis-associated Peritonitis

Interventions

Type	Name	Description
DEVICE	CloudCath Monitoring System	The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.

Timeline

• Start date: 2020-08-19
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2020-08-17
• Last updated: 2023-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study