Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers

Conditions
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Haemofiltration

Intervention / Treatment
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* Device: MediSieve Magnetic Haemofiltration System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers who meet the following criteria will be considered eligible for the study: Male or female, at least 18 and ≤30 years of age; 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: Aged <18 years of age; Aged >30 years of age; Pregnant or lactating females; Individuals < 50kg Individuals with an Hb blood level below 115 g/L Individuals with coagulopathies or under medication that affects normal blood coagulation profile, including COCP in females; Individuals with a previous history of heparin-induced thrombocytopenia; Individuals with known allergy to heparin; Individuals with acute or chronic concomitant conditions; such as diabetes, hypertension, autoimmune disease requiring on going therapy Individuals with history of cancer in the last 5 years;(excluding localised skin cancer or CIS) Individuals with haemoglobinopathy disease; Concurrent participation in another experimental intervention or drug study; Unwilling or unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Healthy volunteer study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All volunteers will receive the same treatment | Device: MediSieve Magnetic Haemofiltration System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.. | 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.. | Through study completion, an average of 6 months |