End Stage Renal Disease Clinical Trial
Official title:
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
Verified date | September 2023 |
Source | CloudCath |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.
Status | Suspended |
Enrollment | 500 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Males or females with end-stage renal disease on peritoneal dialysis for a minimum of 10 days prior to obtaining the specimen. - Specimens shall be leftover (or remnant) from a specimen that has been drained as part of the routine care for the patient. - Specimens shall not contain any individually identifiable information from the patient it was obtained from. Exclusion Criteria: - Patients providing specimens should not be under the administration of any antibiotics other than those utilized for the treatment of peritonitis. - Patients providing specimens should not suffer from a known liver disease or from ovarian or liver cancer. - Patients providing specimens should not be under the administration of calcium channel blockers or amlodipine for less than 30 days prior to providing a specimen. |
Country | Name | City | State |
---|---|---|---|
Mexico | CloudCath Investigational Site | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
CloudCath |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spectral measurements of effluent dialysate solutions | a quantitative analysis of the spectral characteristics of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score. | immediately post dialysis | |
Primary | Conductivity measurements of effluent dialysate solutions. | a quantitative assessment of conductivity of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score. | immediately post dialysis |
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