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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05300191
Other study ID # CC-L-003
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date September 15, 2018
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source CloudCath
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Effluent dialysate
Effluent dialysate samples evaluated for evidence of peritonitis

Locations

Country Name City State
Mexico CloudCath Investigational Site Guadalajara Jalisco

Sponsors (1)

Lead Sponsor Collaborator
CloudCath

Country where clinical trial is conducted

Mexico, 

Outcome

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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