First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings

Diality Inc.

Status

Not yet enrolling

Conditions

End Stage Renal Disease on Dialysis

End Stage Renal Disease

End Stage Kidney Disease

Treatments

Device: Moda-flx Hemodialysis System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06581393

DIA-NSR-001

Details and patient eligibility

About

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 in an ICHD (In-Center Hemodialysis) setting.

Enrollment

8 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).