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

Completed

• Conditions: Peritoneal Dialysis-associated Peritonitis
• Interventions: Device: CloudCath Monitoring System

• Registration Number: NCT04515498
• Lead Sponsor: CloudCath

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-17
• Study Start: 2020-08-19
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CloudCath System	CloudCath Monitoring System	Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis

Primary Outcome Measures

Name	Time	Method
Time of peritonitis detection (vs lab measures)	through 12 months	The time peritonitis is detected by the CloudCath System, as compared to time of laboratory evidence of peritonitis

Secondary Outcome Measures

Name	Time	Method
Time of peritonitis detection (vs clinical measures)	through 12 months	The time peritonitis is detected by the CloudCath System, as compared to time of peritonitis detection by standard clinical means (ISPD guidelines)
Sensitivity and specificity of the CloudCath System detection of peritonitis	through 12 months	Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing
Ability of study participants to use the CloudCath System as intended	through 12-months of study follow-up	Device performance measure; ability to use as intended

Trial Locations

Locations (1)

CloudCath Investigational Site; 🇺🇸 Lakewood, Colorado, United States