A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis
NCT ID: NCT04515498
Last Updated: 2023-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
243 participants
OBSERVATIONAL
2020-08-19
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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CloudCath System
Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis
CloudCath Monitoring System
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.
Interventions
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CloudCath Monitoring System
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.
Eligibility Criteria
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Inclusion Criteria
* provides informed consent
* willing to comply with the requirements of the study
* has cellular data coverage at home
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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CloudCath
INDUSTRY
Responsible Party
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Principal Investigators
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Glenn Chertow, MD
Role: STUDY_DIRECTOR
Stanford University
Locations
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CloudCath Investigational Site
Lakewood, Colorado, United States
Countries
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Other Identifiers
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CC-P-001
Identifier Type: -
Identifier Source: org_study_id
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