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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CloudCath System | Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CloudCath Monitoring System | Device | The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of peritonitis detection (vs lab measures) | The time peritonitis is detected by the CloudCath System, as compared to time of laboratory evidence of peritonitis | through 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time of peritonitis detection (vs clinical measures) | The time peritonitis is detected by the CloudCath System, as compared to time of peritonitis detection by standard clinical means (ISPD guidelines) | through 12 months |
| Sensitivity and specificity of the CloudCath System detection of peritonitis |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the CloudCath System detection of peritonitis and the resolution of peritonitis | Analysis of sensitivity and specificity of the detection of peritonitis and the detection of the resolution of peritonitis, as compared to diagnostic laboratory testing | through 12 months |
| Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis |
Key Inclusion Criteria:
Key Exclusion Criteria:
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Patients currently using home peritoneal dialysis.
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Chertow, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CloudCath Investigational Site | Lakewood | Colorado | 80226 | United States |
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Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing |
| through 12 months |
| Ability of study participants to use the CloudCath System as intended | Device performance measure; ability to use as intended | through 12-months of study follow-up |
Analysis of sensitivity and specificity of the resolution time of peritonitis |
| through 12 months |