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Completed

NCT Number: NCT04515498

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

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.

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Key information

Conditions

Peritoneal Dialysis-associated Peritonitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CloudCath Investigational Site

Lakewood, Colorado, 80226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CloudCath Monitoring System

Device

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

Primary outcomes

  1. Time of peritonitis detection (vs lab measures)

    Time frame: through 12 months

    The time peritonitis is detected by the CloudCath System, as compared to time of laboratory evidence of peritonitis

Secondary outcomes

  1. Time of peritonitis detection (vs clinical measures)

    Time frame: through 12 months

    The time peritonitis is detected by the CloudCath System, as compared to time of peritonitis detection by standard clinical means (ISPD guidelines)

  2. Sensitivity and specificity of the CloudCath System detection of peritonitis

    Time frame: through 12 months

    Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing

  3. Ability of study participants to use the CloudCath System as intended

    Time frame: through 12-months of study follow-up

    Device performance measure; ability to use as intended

Other outcomes

  1. Sensitivity and specificity of the CloudCath System detection of peritonitis and the resolution of peritonitis

    Time frame: through 12 months

    Analysis of sensitivity and specificity of the detection of peritonitis and the detection of the resolution of peritonitis, as compared to diagnostic laboratory testing

  2. Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis

    Time frame: through 12 months

    Analysis of sensitivity and specificity of the resolution time of peritonitis

Sponsors and collaborators

Lead sponsor

CloudCath

Industry

Registry information

Official study title

A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis

Acronym: CATCH

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2020
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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