NCT05217095

Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: D.med Consulting GmbH · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.

Conditions

• Renal Dialysis

Interventions

Type	Name	Description
DEVICE	Convergence Dialyzer	The Convergence dialyzer with design changes made to FX Coral 600 dialyzer will be tested together with Sidecar. In the dialyzer is integrated centrifugal-flow blood pump.The centrifugal-flow blood pump replaces the peristaltic roller pump of the extracorporeal circuit which pumps blood from patient to the dialyzer and from dialyzer to the patient. The centrifugal-flow blood pump is designed to transport blood from the patient to the dialyzer, and after purification, return the blood to patient.

Timeline

• Start date: 2022-01-19
• Primary completion: 2022-01-22
• Completion: 2022-02-22
• First posted: 2022-02-01
• Last updated: 2022-03-02

Locations

1 site across 1 country: North Macedonia