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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peritoneal Dialysis-associated Peritonitis

Intervention / Treatment
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* Device: CloudCath Monitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CloudCath System<br>Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis | Device: CloudCath Monitoring System<br>* The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.<br>|

What is the study measuring?
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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 |