Status:
WITHDRAWN
Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System
Lead Sponsor:
MediSieve Limited
Collaborating Sponsors:
University College London Hospitals
Conditions:
Haemofiltration
Eligibility:
All Genders
18-30 years
Phase:
NA
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 MediSiev...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03786536
Start Date
June 1 2020
End Date
December 31 2020
Last Update
November 18 2023
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