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

NCT05285436 | Unknown FDA Device

• 1 other identifier: CC-P-002
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to peritonitis diagnosis

  The time between detection by the CloudCath System and laboratory confirmation of peritonitis.

  12-months

Secondary Outcomes (4)

• Agreement in peritonitis detection between the CloudCath System and clinical criteria.

  12-months

• Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis

  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.

  12-months

• Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing

  12-months

Study Arms (1)

CloudCath detection

EXPERIMENTAL

Active monitoring of dialysate effluent by the CloudCath System.

Device: CloudCath System

Interventions

CloudCath System DEVICE

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

CloudCath detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently using peritoneal dialysis
• provides informed consent
• willing to comply with the requirements of the study
• has cellular data coverage at home

You may not qualify if:

• 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

Sponsors & Collaborators

• CloudCath: lead

Study Sites (1)

Dialysis Center of Western Massachusetts Llc

Chicopee, Massachusetts, 01020, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Peritonitis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Glenn Chertow, MD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Brian Fisher

CONTACT

+1 (415) 651-3393; brian@cloudcath.com

Concetta Carbonaro

CONTACT

concetta@cloudcath.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All study participants receive a CloudCath Device and use it at home adjunctively to their regular peritoneal dialysis system.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: March 16, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)