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In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device

C

CloudCath

Status

Suspended

Conditions

Peritoneal Dialysis-associated Peritonitis
End Stage Renal Disease

Treatments

Diagnostic Test: Effluent dialysate

Study type

Observational

Funder types

Industry

Identifiers

NCT05300191
CC-L-003

Details and patient eligibility

About

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

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Peritoneal dialysis patients
Description:
Patients undergoing peritoneal dialysis. Patients may be using either Continuous Ambulatory Peritoneal Dialysis (CAPD), Continuous Cycling Peritoneal Dialysis (CCPD) or Intermittent Peritoneal Dialysis (IPD).
Treatment:
Diagnostic Test: Effluent dialysate

Trial contacts and locations

1

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Central trial contact

Brian Fisher

Data sourced from clinicaltrials.gov

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