Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
Part of paid clinical trials in San Dimas, California.
- Sponsor
- Diality Inc.
- Study ID
- NCT06613568
- Status
- Recruiting
Conditions
- End Stage Kidney Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Moda-flx Hemodialysis System™ — DEVICEThe Moda-flx Hemodialysis System™ is a portable hemodialysis system
Study Details
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
Key Dates
- Start date
- Oct 6, 2025
- Status verified
- Aug 2025
- Primary completion
- Mar 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Professional Care and At HomeParticipants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting
Primary Outcome Measure
Weekly Standardized Dialysis Adequacy [ Time Frame: Up to 10 weeks per period ]
Central Contacts
- Michael Gastauer949-916-5851
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North America Research Institute | San Dimas | California | 91773 | |
| Nephrology Associates of Knoxville | Knoxville | Tennessee | 37920 | |
| aQua Research Institute, LLC | Houston | Texas | 77058 | |
| University of Washington | Seattle | Washington | 98104 | Lori Linke |
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