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Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers

NCT05713188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-02-06

No results posted yet for this study

Summary

This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers

Conditions

  • Haemofiltration

Interventions

DEVICE

MediSieve Magnetic Haemofiltration System

The MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream. Healthy volunteers will undergo filtration for 5 hours.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • MediSieve Limited

    lead INDUSTRY

Principal Investigators

  • Matthijs Kox, PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2022-11-17
Completion
2022-11-30

Countries

  • Netherlands

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 NCT05713188 on ClinicalTrials.gov