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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515498
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2020
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
CloudCath

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.

Condition or disease Intervention/treatment
Peritoneal Dialysis-associated Peritonitis Device: CloudCath Monitoring System

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 186 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort Intervention/treatment
CloudCath System
Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis
Device: CloudCath Monitoring System
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients currently using home peritoneal dialysis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515498


Locations
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United States, Colorado
CloudCath Investigational Site
Lakewood, Colorado, United States, 80226
Sponsors and Collaborators
CloudCath
Investigators
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Study Director: Glenn Chertow, MD Stanford University
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Responsible Party: CloudCath
ClinicalTrials.gov Identifier: NCT04515498    
Other Study ID Numbers: CC-P-001
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infections
Peritoneal Diseases
Digestive System Diseases