Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

MediSieve Limited

Overview

This is a single centre, prospective, non-randomised healthy volunteer study to be undertaken at University College Hospital London. The study will be used to demonstrate the safe use of the MediSieve blood filtration system in healthy volunteers prior to undertaking clinical trials on patients with relevant pathologies.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Haemofiltration

Interventions

MediSieve Magnetic Haemofiltration SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Healthy volunteers who meet the following criteria will be considered eligible for the study: 1. Male or female, at least 18 and ≤30 years of age; 2. Able to comprehend and sign the Informed Consent prior to enrolment in the study. Exclusion Criteria: Volunteers who meet the following criteria will NOT be eligible for the study: 1. Aged \<18 years of age; 2. Aged \>30 years of age; 3. Pregnant or lactating females; 4. Individuals \< 50kg 5. Individuals with an Hb blood level below 115 g/L 6. Individuals with coagulopathies or under medication that affects normal blood coagulation profile, including COCP in females; 7. Individuals with a previous history of heparin-induced thrombocytopenia; 8. Individuals with known allergy to heparin; 9. Individuals with acute or chronic concomitant conditions; such as diabetes, hypertension, autoimmune disease requiring on going therapy 10. Individuals with history of cancer in the last 5 years;(excluding localised skin cancer or CIS) 11. Individuals with haemoglobinopathy disease; 12. Concurrent participation in another experimental intervention or drug study; 13. Unwilling or unable to provide informed consent.

Outcomes

Primary Outcomes

Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events.

Treatment-Emergent Adverse Events during the study and the 6 month period after volunteers exit the study. Definitions from ISO14155 will be used to categorise Adverse Events

Time frame: During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment

Secondary Outcomes

Performance of device during use. Time required for the user to set up and shut down the haemofiltration pump..

Set up and shut down duration. The time, in minutes, to set up and shut down the haemofiltration pump will be recorded for each participant..

Time frame: Through study completion, an average of 6 months...

Performance of device during use will be assessed by the incidence of flow-rate alarms on the haemofiltration pump during use.

Device performance will be assessed by the incidence of alarms on the haemofiltration pump that are triggered by blood flow through the pump falling below pre-set level..

Time frame: Through study completion, an average of 6 months

Data from ClinicalTrials.gov

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