Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System
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|ClinicalTrials.gov Identifier: NCT03786536|
Recruitment Status : Not yet recruiting
First Posted : December 26, 2018
Last Update Posted : March 4, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Haemofiltration||Device: MediSieve Magnetic Haemofiltration System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Healthy volunteer study|
|Masking:||None (Open Label)|
|Official Title:||Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
All volunteers will receive the same treatment
Device: MediSieve Magnetic Haemofiltration System
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.
- Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events. [ Time Frame: 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
- Performance of device during use. Time required for the user to set up and shut down the haemofiltration pump.. [ Time Frame: 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. [ Time Frame: 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..
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786536
|Contact: Cristina Blanco Andujar, PhD||+44 (0)7533 email@example.com|
|Study Director:||Cristina Blanco Andujar, PhD||MediSieve Limited|