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Completed
NCT05713188
Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
Conditions: Haemofiltration
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 6
Sponsor: MediSieve Limited
Location: Netherlands
Summary
This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers
Eligibility Criteria
Inclusion Criteria:Male or female, ≥18 and ≤50 years of ageAble to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.Exclusion Criteria:BMI <18.5 or >30 kg/m2Chronic medication use (except contraception)Pregnant or lactating femalesKnown anaphylaxis or hypersensitivity to any (non-)investigational products or their excipientsHistory or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema)History or signs of haematological diseaseHistory or signs of thromboembolic disordersHistory of (intracranial) aneurysmal or haemorrhagic diseasesHistory of any disease associated with immune deficiencyHistory of cancer in the last 5 years (excluding localised skin cancer or CIS)History of heparin-induced thrombocytopenia (HIT)History of peptic / gastric ulcer diseaseFamily history of haemorrhagic or thromboembolic disorders (<50 years of age)Thrombocytopenia (<150*109/ml) or anaemia (males: haemoglobin < 8.0 mmol/L, females: haemoglobin < 7.4 mmol/L)History, signs or symptoms of cardiovascular disease, in particular:Prone to vagal collapseHistory of atrial or ventricular arrhythmiaCardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch blockHypertension (defined as RR systolic > 160 or RR diastolic > 90 mmHg)Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg)Renal impairment (defined as plasma creatinine >120 μmol/L)Liver enzyme abnormalities (above 2x the upper limit of normal)Signs of infection (CRP > 20 mg/L, White Blood Count > 12x109/L or < 4x109/L)Clinically significant acute illness, including infections or trauma, within 1 month of the experiment dayParticipation in an experimental intervention or drug trial or donation of blood within 3 months prior to the experiment dayRecent hospital admission or surgery with general anaesthesia within 3 months prior to experiment dayUse of recreational drugs within 2 weeks of the experiment dayInability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study
Source: ClinicalTrials.gov (NCT05713188). StuddyBuddy aggregates publicly available trial information.
