Clinical investigation of the safety of the MediSieve Magnetic Haemofiltration System in healthy volunteers.

Completed

• Conditions: blood poisoning; Sepsis; 10027665; 10004018

• Registration Number: NL-OMON51755
• Lead Sponsor: MediSieve Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: Incidence of Adverse Events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety: Vital signs, blood inflammatory and laboratory safety parameters.<br /><br>Miscellaneous: User (MD-investigator and research nurse) feedback</p><br>