RecruitingNot ApplicableNCT06613568

Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants

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


Sponsor

Diality Inc.

Enrollment

50 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new home hemodialysis system called Moda-flx, which is designed to allow patients with end-stage kidney disease to do their dialysis at home rather than traveling to a clinic multiple times per week. The study evaluates both professional-setting use and safe home use with a trained care partner. **You may be eligible if...** - You are between 18 and 80 years old, and your care partner is at least 18 years old - You have end-stage kidney disease and are already receiving maintenance dialysis - Your dialysis is currently adequate (meeting standard treatment targets) - You have a willing and available care partner **You may NOT be eligible if...** - You have had a recent hospitalization or major health event making home dialysis unsafe - You have certain vascular access issues - You are unable to train with a care partner or manage home use - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEModa-flx Hemodialysis System™

The Moda-flx Hemodialysis System™ is a portable hemodialysis system


Locations(4)

North America Research Institute

San Dimas, California, United States

Nephrology Associates of Knoxville

Knoxville, Tennessee, United States

aQua Research Institute, LLC

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

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NCT06613568


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