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

Peritoneal Dialysis-associated Peritonitis Clinical Trial

— CATCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515498
• Other study ID #: CC-P-001
• Status: Completed
• Start date: August 19, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: CloudCath
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis-associated Peritonitis
• Peritonitis

Intervention

Device:
• CloudCath Monitoring System
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.

Locations

Country	Name	City	State
United States	CloudCath Investigational Site	Lakewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
CloudCath

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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