Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

Haemofiltration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03786536
• Other study ID #: MSV_2018/01
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2023
• Source: MediSieve Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Haemofiltration

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MediSieve Limited	University College London Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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...
Secondary	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