Status:
COMPLETED
A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis
Lead Sponsor:
CloudCath
Conditions:
Peritoneal Dialysis-associated Peritonitis
Eligibility:
All Genders
18+ years
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Key
- currently using peritoneal dialysis
- provides informed consent
- willing to comply with the requirements of the study
- has cellular data coverage at home
- Key
Exclusion
- 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
Key Trial Info
Start Date :
August 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT04515498
Start Date
August 19 2020
End Date
March 31 2023
Last Update
May 30 2023
Active Locations (1)
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1
CloudCath Investigational Site
Lakewood, Colorado, United States, 80226