Clinical trial NCT04515498: A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis
Official title: A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis-associated Peritonitis
Lead sponsor: CloudCath
Sponsor class: INDUSTRY
First posted: 2020-08-17
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients currently using home peritoneal dialysis.

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 to detect such infections.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of peritonitis detection (vs lab measures)
timeFrame: through 12 months
Secondary outcomes:
measure: Time of peritonitis detection (vs clinical measures)
timeFrame: through 12 months
measure: Sensitivity and specificity of the CloudCath System detection of peritonitis
timeFrame: through 12 months
measure: Ability of study participants to use the CloudCath System as intended
timeFrame: through 12-months of study follow-up
Other outcomes:
measure: Sensitivity and specificity of the CloudCath System detection of peritonitis and the resolution of peritonitis
timeFrame: through 12 months
measure: Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis
timeFrame: through 12 months
Locations:
city: Lakewood
country: United States
facility: CloudCath Investigational Site
state: Colorado
Study officials:
affiliation: Stanford University
name: Glenn Chertow, MD
role: STUDY_DIRECTOR
References: