To determine safety of the MediSieve Magnetic Hemofiltration System in healthy volunteers.
ID
Source
Brief title
Condition
- Immune disorders NEC
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Incidence of Adverse Events
Secondary outcome
Safety: Vital signs, blood inflammatory and laboratory safety parameters.
Miscellaneous: User (MD-investigator and research nurse) feedback
Background summary
The intended purpose of all products in the MediSieve *Magnetic Sieve* family
of medical devices is to filter selected moieties from blood in an
extracorporeal circuit by magnetic means. The *MediSieve Magnetic
Haemofiltration System* (MMHS) has been developed for the treatment of severe
malaria. Malaria-infected erythrocytes are weakly magnetic due to the presence
of haemozoin, a waste product produced by the parasite and stored within the
infected cell. The device, when placed in an extracorporeal circuit, can be
used to remove infected erythrocytes from the circulating blood, and reduce the
parasitaemia affecting the patient. Clinical testing of the MediSieve Magnetic
Haemofiltration System on healthy volunteers is therefore necessary.
Study objective
To determine safety of the MediSieve Magnetic Hemofiltration System in healthy
volunteers.
Study design
Non-comparative study in healthy volunteers.
Intervention
Subjects will receive a femoral line and undergo blood filtration using the
MediSieve Magnetic Haemofiltration System for five consecutive hours. Flow rate
is fixed at 120 ml/min with a maximum deviation of 20 mL/min. Vital signs will
be continuously monitored. Blood samples will be obtained serially to determine
laboratory safety and immunological parameters.
Study burden and risks
Subjects will visit the research unit four times: once for the screening, once
for blood filtration using the MediSieve Magnetic Hemofiltration System, and
twice during follow-up visits (24 hours and 7 days post-filtration. Total time
investment will be ± 11 hours in nine days. The MediSieve Magnetic
Hemofiltration System has been extensively tested in benchtop and animal
experiments. A comprehensive risk assessment has been performed according to
ISO EN 14971. Risk reduction steps have been implanted. Risks which cannot be
eliminated have been reduced to as low as reasonably possible, and the study
participants will be informed of all identified potential risks. In total, a
maximum of 350 mL blood will be obtained, which is less than in many of our
previous studies, which never resulted in adverse events. Subjects will not
benefit directly from participation to the study. The study is classified as a
*negligible risk* (low risk of moderate harm). A subject fee is provided.
Chancery Lane 48
London WC2A 1JF
GB
Chancery Lane 48
London WC2A 1JF
GB
Listed location countries
Age
Inclusion criteria
- Written informed consent
- Age >= 18 and <= 50 years
- Healthy (as determined b y medical history, physical examination, vital
signs, 12-lead electrocardiogram (ECG) and routine clinical laboratory
parameters)
Exclusion criteria
- Chronic medication use (except contraception)
- Pregnant or lactating females
- Hypersensitivity to any of the (non)investigational products or their
excipients
- History of:
- Aneurysmal or hemorrhagic disease
- Heparin-induced thrombocytopenia
- Renal or hepatic impairment
- Peptic or gastric ulcer disease
- Family history of haemorrhagic or thromboembolic disorders (<50 years of age)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80026.000.21 |