Clinical trial NCT05285436: A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
Official title: A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using In-Home Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Peritoneal Dialysis-associated Peritonitis
Peritonitis
Lead sponsor: CloudCath
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants receive a CloudCath Device and use it at home adjunctively to their regular peritoneal dialysis system.
Primary purpose: DIAGNOSTIC

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 system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider.

Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.

Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.

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 to peritonitis diagnosis
timeFrame: 12-months
Secondary outcomes:
measure: Agreement in peritonitis detection between the CloudCath System and clinical criteria.
timeFrame: 12-months
measure: Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis
timeFrame: 12-months
measure: Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.
timeFrame: 12-months
measure: Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing
timeFrame: 12-months
Other outcomes:
Locations:
city: Chicopee
country: United States
facility: Dialysis Center of Western Massachusetts Llc
state: Massachusetts
Study officials:
affiliation: Stanford University
name: Glenn Chertow, MD
role: STUDY_DIRECTOR
References: