An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System
- Conditions
- End Stage Renal Disease
- Interventions
- Device: HemoCare™ Hemodialysis System
- Registration Number
- NCT04198012
- Lead Sponsor
- Deka Research and Development
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description The HemoCare™ Hemodialysis System HemoCare™ Hemodialysis System 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.
- Primary Outcome Measures
Name Time Method Safety Measures 52 weeks 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Dialysis Clinic, Inc.
🇺🇸Nashville, Tennessee, United States
The Rogosin Institute
🇺🇸New York, New York, United States
Wellbound South Austin
🇺🇸Austin, Texas, United States
DCI North Brunswick
🇺🇸North Brunswick, New Jersey, United States
Wellbound North Austin
🇺🇸Austin, Texas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States