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Diagnostic Device
CloudCath Monitoring for Peritoneal Dialysis Infections (ACT Trial)
N/A
Recruiting
Research Sponsored by CloudCath
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently using peritoneal dialysis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
ACT Trial Summary
This trial will test if the CloudCath device, which uses a small sensor to monitor patients' dialysis fluid for changes that may indicate an infection, can detect these infections as fast or faster than the current standard methods.
Who is the study for?
This trial is for individuals currently using in-home peritoneal dialysis, who can give informed consent and will follow the study's requirements. They must have cellular data at home. People with recent cancer treatments, peritonitis, current infections, or involvement in other studies that could affect results are excluded.Check my eligibility
What is being tested?
The CloudCath System is being tested to see if it can detect infections from peritoneal dialysis quicker or as quickly as existing methods. The goal is to improve early infection detection which is crucial for patients undergoing this treatment.See study design
What are the potential side effects?
Since the CloudCath System is a diagnostic device rather than a medication, traditional side effects like those seen with drugs are not expected. However, there may be risks associated with incorrect readings leading to delayed infection management.
ACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on peritoneal dialysis.
ACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to peritonitis diagnosis
Secondary outcome measures
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.
Agreement in peritonitis detection between the CloudCath System and clinical criteria.
+1 moreACT Trial Design
1Treatment groups
Experimental Treatment
Group I: CloudCath detectionExperimental Treatment1 Intervention
Active monitoring of dialysate effluent by the CloudCath System.
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Who is running the clinical trial?
CloudCathLead Sponsor
3 Previous Clinical Trials
1,243 Total Patients Enrolled
Glenn Chertow, MDStudy DirectorStanford University
5 Previous Clinical Trials
3,169 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on peritoneal dialysis.I have not had signs of an infection in the last 14 days.I have had cancer treatment within the last 6 months.I was diagnosed with peritonitis in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: CloudCath detection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could individuals still qualify for this clinical experimentation?
"The clinical trial data hosted on clinicaltrials.gov reveals that this particular medical investigation is no longer recruiting patients, as it was first posted in March 16th of 2022 and last updated in July 20th 2022. Nonetheless, 200 other trials are at the moment actively welcoming volunteers for enrollment."
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