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

CloudCath243 enrolled

Overview

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.

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

243

Conditions

Peritoneal Dialysis-associated Peritonitis

Interventions

CloudCath Monitoring SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CloudCath Investigational Site

Lakewood, Colorado, United States

Outcomes

Primary Outcomes

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

Time frame: through 12 months

Secondary Outcomes

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)

Time frame: 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

Time frame: through 12 months

Ability of study participants to use the CloudCath System as intended

Device performance measure; ability to use as intended

Time frame: through 12-months of study follow-up

Data from ClinicalTrials.gov

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