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

A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using 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: Recruiting
• Conditions: End Stage Renal Disease; Peritonitis; Peritoneal Dialysis-associated Peritonitis
• Intervention / Treatment: Device: CloudCath 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 314
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Fisher; Phone Number: +1 (415) 651-3393; Email: brian@cloudcath.com
• Study Contact Backup: Name: Concetta Carbonaro; Email: concetta@cloudcath.com

Study Locations

• United States
  • Massachusetts
    • Chicopee, Massachusetts, United States, 01020
      • Recruiting
      • Dialysis Center of Western Massachusetts Llc
      • Contact: Concetta Carbonaro

Participation Criteria

Eligibility Criteria

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

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?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CloudCath detection; Active monitoring of dialysate effluent by the CloudCath System.	Device: CloudCath System; The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to peritonitis diagnosis	The time between detection by the CloudCath System and laboratory confirmation of peritonitis.	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement in peritonitis detection between the CloudCath System and clinical criteria.	clinical criteria include: white blood cells (WBC) (>100 cells per microliter or >0.1 x10^9/L), polymorphonuclear cells (PMN) (>50%), microbiology culture results, gram staining, and peritonitis symptoms	12-months
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis	Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal). Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues).	12-months
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.	Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events.	12-months
Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing	Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing	12-months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Peritoneal Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Intraabdominal Infections; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Peritonitis
• Other Study ID Numbers: CC-P-002

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