Status:
COMPLETED
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
Lead Sponsor:
Diality Inc.
Conditions:
End Stage Renal Disease
End Stage Renal Disease on Dialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care i...
Eligibility Criteria
Inclusion
- 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 consent.
- Must sign the informed consent and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Understand the nature of the procedures and the requirements of the Study.
Exclusion
- Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist.
- In the opinion of the treating nephrologist, any other reason in which study participation would result in undue risk, including but not limited to protocol required prescription parameters.
- Are contraindicated for or not indicated to use the Moda-flx Hemodialysis System™ according to the Instructions For Use (IFU).
Key Trial Info
Start Date :
December 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06581393
Start Date
December 9 2024
End Date
April 28 2025
Last Update
June 22 2025
Active Locations (1)
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1
North America Research Institute
Ontario, California, United States, 91762