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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2023
Source CloudCath
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Peritoneal Dialysis-associated Peritonitis
  • Peritonitis

Intervention

Device:
CloudCath Monitoring System
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.

Locations

Country Name City State
United States CloudCath Investigational Site Lakewood Colorado

Sponsors (1)

Lead Sponsor Collaborator
CloudCath

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT03264625 - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis Phase 2
Suspended NCT05300191 - In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
Completed NCT03685747 - Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis Phase 1
Recruiting NCT03046511 - Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter. Phase 3
Recruiting NCT05285436 - A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis N/A
Recruiting NCT05971537 - Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis Phase 4
Recruiting NCT05860270 - Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis Phase 4
Completed NCT01293799 - Prevention of Peritonitis in Peritoneal Dialysis N/A
Withdrawn NCT03675854 - Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis Phase 4
Completed NCT05450523 - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol
Terminated NCT00801775 - Improved Diagnosis of Peritoneal Dialysis Peritonitis by Calorimetry N/A