NCT05713188

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: MediSieve Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The MediSieve Magnetic Haemofiltration System (MMHS) is a system to filter selected moieties from blood in an extracorporeal circuit by magnetic means. Initially, it is developed for the treatment of severe malaria to capture malaria-infected erythrocytes (who are weakly magnetic) to reduce the parasitaemia. However, the use of MMHS can be extended, with the use of antibodies coupled to magnetic beads, to other diseases, such as sepsis. The MMHS has to be used first in healthy volunteers to determine its clinical safety. To this end, 6 healthy male and female volunteers (ratio 1:1) will undergo blood filtration using the MediSieve Magnetic Haemofiltration System (without magnetic beads) for five consecutive hours. Vital signs will be continuously monitored and blood samples will be obtained serially to determine laboratory safety and immunological parameters. Furthermore, volunteers will have two follow up visits at 24 hours and 7 days post filtration.

Conditions

• Haemofiltration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2022-11-17
• Completion: 2022-11-30
• First posted: 2023-02-06
• Last updated: 2023-02-06

Locations

1 site across 1 country: Netherlands