Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Participants With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens
Diality Inc.
Summary
The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Are between 18 and 80 years of age and Care Partner is at least 18 years of age at the time of signing consent. * Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Screening Period * Have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of Screening * Can successfully com…
Interventions
- DeviceModa-flx Hemodialysis System™
The Moda-flx Hemodialysis System™ is a portable hemodialysis system
Locations (4)
- North America Research InstituteSan Dimas, California
- Nephrology Associates of KnoxvilleKnoxville, Tennessee
- aQua Research Institute, LLCHouston, Texas
- University of WashingtonSeattle, Washington