An interventional study of CloudCath System in End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis and Peritonitis, sponsored by CloudCath. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by CloudCath · Not applicable, Interventional, and Diagnostic
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.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 314 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →CloudCath is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active monitoring of dialysate effluent by the CloudCath System.
Device: CloudCath System
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.
Time to peritonitis diagnosis
The time between detection by the CloudCath System and laboratory confirmation of peritonitis.
Time frame: 12-months
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
Time frame: 12-months
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).
Time frame: 12-months
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.
Time frame: 12-months
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
Time frame: 12-months
Plan to share: No
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