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