NCT05285436

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (estimated)
• 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 system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider. Following enrollment, Study Participants will use the CloudCath System for 12 continuous months. Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.

Conditions

• End Stage Renal Disease
• Peritoneal Dialysis-associated Peritonitis
• Peritonitis

Interventions

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

Timeline

• Start date: 2022-03-16
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-03-17
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study