Assessing a device for detecting infections in home peritoneal dialysis patients
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using In-Home Peritoneal Dialysis
This study is testing a new device that helps people on home peritoneal dialysis quickly find out if they have infections, to see if it works better than the usual methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CloudCath Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicopee, Massachusetts) |
| Trial ID | NCT05285436 on ClinicalTrials.gov |
What this trial studies
This study evaluates the CloudCath System's ability to quickly detect infections related to peritoneal dialysis, specifically peritonitis. Participants will connect the device to their home dialysis unit, which analyzes the dialysis solution for signs of infection and alerts both the patient and healthcare provider. The study will last for 12 months, comparing results from this study to a previous study where notification capabilities were disabled. The goal is to determine if this device can improve the speed and accuracy of infection detection compared to standard methods.
Who should consider this trial
Good fit: Ideal candidates are individuals currently using peritoneal dialysis who can provide informed consent and have cellular data coverage at home.
Not a fit: Patients with active infections, recent peritonitis diagnoses, or those participating in other investigational studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could lead to earlier detection and treatment of infections in patients undergoing peritoneal dialysis, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using similar devices for infection detection, but this specific approach with the CloudCath System is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicopee, Massachusetts
- Dialysis Center of Western Massachusetts Llc — Chicopee, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Brian Fisher
- Email: brian@cloudcath.com
- Phone: +1 (415) 651-3393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.