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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05285436
Other study ID # CC-P-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2022
Est. completion date December 2024

Study information

Verified date September 2023
Source CloudCath
Contact Brian Fisher
Phone +1 (415) 651-3393
Email brian@cloudcath.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 314
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CloudCath System
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.

Locations

Country Name City State
United States Dialysis Center of Western Massachusetts Llc Chicopee Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
CloudCath

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to peritonitis diagnosis The time between detection by the CloudCath System and laboratory confirmation of peritonitis. 12-months
Secondary Agreement in peritonitis detection between the CloudCath System and clinical criteria. clinical criteria include: white blood cells (WBC) (>100 cells per microliter or >0.1 x10^9/L), polymorphonuclear cells (PMN) (>50%), microbiology culture results, gram staining, and peritonitis symptoms 12-months
Secondary Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal).
Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues).
12-months
Secondary Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event. Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events. 12-months
Secondary Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing 12-months
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