NCT06613568

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Diality Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• End Stage Kidney Disease

Interventions

Type	Name	Description
DEVICE	Moda-flx Hemodialysis System™	The Moda-flx Hemodialysis System™ is a portable hemodialysis system

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2024-09-26
• Last updated: 2025-11-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study