Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

NCT03786536 | Withdrawn

• 1 other identifier: MSV_2018/01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Haemofiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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...

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

All volunteers will receive the same treatment

Device: MediSieve Magnetic Haemofiltration System

Interventions

MediSieve Magnetic Haemofiltration System 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.

Treatment

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MediSieve Limited: lead
• University College London Hospitals: collaborator

Study Officials

• Cristina Blanco Andujar, PhD

  MediSieve Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy volunteer study

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 26, 2018
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11