Haemofiltration
Conditions
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.
Interventions
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.
Sponsors
University College London Hospitals
MediSieve Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Healthy volunteer study
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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.. |
Outcome results
None listed