A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis (ACT)
Primary Purpose
End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis, Peritonitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CloudCath System
Sponsored by
About this trial
This is an interventional diagnostic trial for End Stage Renal Disease
Eligibility 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
Sites / Locations
- Dialysis Center of Western Massachusetts LlcRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CloudCath detection
Arm Description
Active monitoring of dialysate effluent by the CloudCath System.
Outcomes
Primary Outcome Measures
Time to peritonitis diagnosis
The time between detection by the CloudCath System and laboratory confirmation of peritonitis.
Secondary Outcome Measures
Agreement in peritonitis detection between the CloudCath System and clinical criteria.
clinical criteria include: white blood cells (WBC) (>100 cells per microliter or >0.1 x10^9/L), polymorphonuclear cells (PMN) (>50%), microbiology culture results, gram staining, and peritonitis symptoms
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis
Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal).
Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues).
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.
Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events.
Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing
Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05285436
Brief Title
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
Acronym
ACT
Official Title
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using In-Home Peritoneal Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CloudCath
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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 system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis, Peritonitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All study participants receive a CloudCath Device and use it at home adjunctively to their regular peritoneal dialysis system.
Masking
None (Open Label)
Allocation
N/A
Enrollment
314 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CloudCath detection
Arm Type
Experimental
Arm Description
Active monitoring of dialysate effluent by the CloudCath System.
Intervention Type
Device
Intervention Name(s)
CloudCath System
Intervention Description
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.
Primary Outcome Measure Information:
Title
Time to peritonitis diagnosis
Description
The time between detection by the CloudCath System and laboratory confirmation of peritonitis.
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Agreement in peritonitis detection between the CloudCath System and clinical criteria.
Description
clinical criteria include: white blood cells (WBC) (>100 cells per microliter or >0.1 x10^9/L), polymorphonuclear cells (PMN) (>50%), microbiology culture results, gram staining, and peritonitis symptoms
Time Frame
12-months
Title
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis
Description
Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal).
Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues).
Time Frame
12-months
Title
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.
Description
Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events.
Time Frame
12-months
Title
Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing
Description
Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing
Time Frame
12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Fisher
Phone
+1 (415) 651-3393
Email
brian@cloudcath.com
First Name & Middle Initial & Last Name or Official Title & Degree
Concetta Carbonaro
Email
concetta@cloudcath.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Chertow, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Dialysis Center of Western Massachusetts Llc
City
Chicopee
State/Province
Massachusetts
ZIP/Postal Code
01020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Concetta Carbonaro
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
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