A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis

NCT04515498 | Completed FDA Device

• 1 other identifier: CC-P-001
• Study Type: observational
• Target: 243
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Dialysis-associated Peritonitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time of peritonitis detection (vs clinical measures)

  through 12 months

• Sensitivity and specificity of the CloudCath System detection of peritonitis

  through 12 months

• Ability of study participants to use the CloudCath System as intended

  through 12-months of study follow-up

Other Outcomes (2)

• Sensitivity and specificity of the CloudCath System detection of peritonitis and the resolution of peritonitis

  through 12 months

• Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis

  through 12 months

Study Arms (1)

CloudCath System

Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis

Device: CloudCath Monitoring System

Interventions

CloudCath Monitoring System DEVICE

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

CloudCath System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients currently using home peritoneal dialysis.

You may qualify if:

• currently using peritoneal dialysis
• provides informed consent
• willing to comply with the requirements of the study
• has cellular data coverage at home

You may not qualify if:

• 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

Sponsors & Collaborators

• CloudCath: lead

Study Sites (1)

CloudCath Investigational Site

Lakewood, Colorado, 80226, United States

Location

Study Officials

• Glenn Chertow, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: August 19, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)