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

A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis-associated Peritonitis
• Intervention / Treatment: Device: CloudCath Monitoring System

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 Type: Observational
• Enrollment (Actual): 243

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lakewood, Colorado, United States, 80226
      • CloudCath Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients currently using home peritoneal dialysis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CloudCath System; Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis	Device: CloudCath Monitoring System; The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of the CloudCath System detection of peritonitis and the resolution of peritonitis	Analysis of sensitivity and specificity of the detection of peritonitis and the detection of the resolution of peritonitis, as compared to diagnostic laboratory testing	through 12 months
Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis	Analysis of sensitivity and specificity of the resolution time of peritonitis	through 12 months

Collaborators and Investigators

• Sponsor: CloudCath
• Investigators: Study Director: Glenn Chertow, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: CC-P-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No