An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System
Not Applicable
Completed
- Conditions
- End Stage Renal Disease
- 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
- 25
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Subjects With Safety Event 52 weeks The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
DCI North Brunswick
🇺🇸North Brunswick, New Jersey, United States
The Rogosin Institute
🇺🇸New York, New York, United States
Dialysis Clinic, Inc.
🇺🇸Nashville, Tennessee, United States
Wellbound South Austin
🇺🇸Austin, Texas, United States
Wellbound North Austin
🇺🇸Austin, Texas, United States
University of Mississippi Medical Center🇺🇸Jackson, Mississippi, United States