Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

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

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 Overview

• Status: Withdrawn
• Conditions: Haemofiltration
• Intervention / Treatment: Device: MediSieve Magnetic Haemofiltration System

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; All volunteers will receive the same treatment	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MediSieve Limited
• Collaborators: University College London Hospitals
• Investigators: Study Director: Cristina Blanco Andujar, PhD, MediSieve Limited

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2020
• Primary Completion (Estimated): September 1, 2020
• Study Completion (Estimated): December 31, 2020

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MSV_2018/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No