Peritoneal Dialysis-associated Peritonitis
Conditions
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.
Interventions
DEVICECloudCath Monitoring System
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.
Sponsors
CloudCath
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of peritonitis detection (vs lab measures) | through 12 months | The time peritonitis is detected by the CloudCath System, as compared to time of laboratory evidence of peritonitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of peritonitis detection (vs clinical measures) | through 12 months | The time peritonitis is detected by the CloudCath System, as compared to time of peritonitis detection by standard clinical means (ISPD guidelines) |
| Sensitivity and specificity of the CloudCath System detection of peritonitis | through 12 months | Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing |
| Ability of study participants to use the CloudCath System as intended | through 12-months of study follow-up | Device performance measure; ability to use as intended |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of the CloudCath System detection of peritonitis and the resolution of peritonitis | through 12 months | Analysis of sensitivity and specificity of the detection of peritonitis and the detection of the resolution of peritonitis, as compared to diagnostic laboratory testing |
| Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis | through 12 months | Analysis of sensitivity and specificity of the resolution time of peritonitis |
Countries
United States
Outcome results
None listed