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

NCT05217095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-03-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fresenius Medical Care Deutschland GmbH

    collaborator INDUSTRY

  • D.med Consulting GmbH

    lead INDUSTRY

Principal Investigators

  • Elena Babalj-Banskolieva, Dr. · Specialized Hospital for Nephrology and Dialysis Diamed

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2022-01-22
Completion
2022-02-22

Countries

  • North Macedonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217095 on ClinicalTrials.gov