Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

Not Applicable

Withdrawn

• Conditions: Haemofiltration
• Interventions: Device: MediSieve Magnetic Haemofiltration System

• Registration Number: NCT03786536
• Lead Sponsor: MediSieve Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-26
• Study Start: 2020-06-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	MediSieve Magnetic Haemofiltration System	All volunteers will receive the same treatment

Primary Outcome Measures

Name	Time	Method
Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events.	During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment	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

Secondary Outcome Measures

Name	Time	Method
Performance of device during use. Time required for the user to set up and shut down the haemofiltration pump..	Through study completion, an average of 6 months...	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..
Performance of device during use will be assessed by the incidence of flow-rate alarms on the haemofiltration pump during use.	Through study completion, an average of 6 months	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..