Status:
UNKNOWN
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
Lead Sponsor:
CloudCath
Conditions:
End Stage Renal Disease
Peritoneal Dialysis-associated Peritonitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT05285436
Start Date
March 16 2022
End Date
December 1 2024
Last Update
September 21 2023
Active Locations (1)
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1
Dialysis Center of Western Massachusetts Llc
Chicopee, Massachusetts, United States, 01020