An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System

Study Overview
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Brief Summary
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This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.

Official Title
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An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: HemoCare™ Hemodialysis System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator. Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System. Have a trained study care partner able to support subject for all at-home study treatments. Subject and care partner can read and understand English and provide written informed consent. Have a stable functioning vascular access as judged by the treating physician. Exclusion Criteria: Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study. Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study. Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures. Are participating or planning to participate in any other interventional studies except DKPL-00057-001.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open-label rollover study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The HemoCare™ Hemodialysis System<br>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. | Device: HemoCare™ Hemodialysis System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Measures | Proportion of subjects having at least one of the following: anticipated Adverse Event, anticipated Serious Adverse Event, unanticipated Adverse Event, unanticipated Serious Adverse Event, device-related Adverse Event, device-related Serious Adverse Event | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HemoCare™ Hemodialysis System, HemoCare™, Hemodialysis