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Hemodialysis System
HemoCare™ Hemodialysis System for Kidney Failure
N/A
Waitlist Available
Research Sponsored by Deka Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of using the HemoCare™ Hemodialysis System at home. The machine cleans the blood for patients with kidney problems. The study aims to ensure that using this machine at home is safe. Home hemodialysis has been a therapeutic option for almost 4 decades.
Eligible Conditions
- Kidney Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 31 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Performance Endpoint
Primary Safety Endpoint
Secondary study objectives
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
+1 moreOther study objectives
Descriptive summary of the time(s) to resolve HemoCareTM device alarms
Descriptive summary statistics of successful and unsuccessful completion of subjects completing HemoCareTM training and entering Unassisted Home Evaluation Period
Patient Recovery Time Questionnaire
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: The HemoCare™ Hemodialysis SystemExperimental Treatment1 Intervention
The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HemoCare™ Hemodialysis System
2019
N/A
~70
Find a Location
Who is running the clinical trial?
CVS Kidney Care LLC.UNKNOWN
1 Previous Clinical Trials
26 Total Patients Enrolled
Deka Research and DevelopmentLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
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