Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-31

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.

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Detailed Description

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Conditions

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Haemofiltration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Healthy volunteer study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

All volunteers will receive the same treatment

Group Type EXPERIMENTAL

MediSieve Magnetic Haemofiltration System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes