Peritoneal Dialysis-associated Peritonitis Clinical Trial
— CATCHOfficial title:
A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis
NCT number | NCT04515498 |
Other study ID # | CC-P-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 19, 2020 |
Est. completion date | March 31, 2023 |
Verified date | May 2023 |
Source | CloudCath |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 243 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
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 |
Country | Name | City | State |
---|---|---|---|
United States | CloudCath Investigational Site | Lakewood | Colorado |
Lead Sponsor | Collaborator |
---|---|
CloudCath |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis | Analysis of sensitivity and specificity of the resolution time of peritonitis | through 12 months | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Sensitivity and specificity of the CloudCath System detection of peritonitis | Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing | through 12 months | |
Secondary | 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 |
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