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Approval of specific study by UK MHRA not received. Study performed in different circumstances and with different clinical sites / partners.
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| Name | Class |
|---|---|
| University College London Hospitals | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All volunteers will receive the same treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MediSieve Magnetic Haemofiltration System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events. | 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 | During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of device during use. Time required for the user to set up and shut down the haemofiltration pump.. | 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.. | Through study completion, an average of 6 months... |
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Inclusion Criteria:
Healthy volunteers who meet the following criteria will be considered eligible for the study:
Exclusion Criteria:
Volunteers who meet the following criteria will NOT be eligible for the study:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Blanco Andujar, PhD | MediSieve Limited | Study Director |
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Healthy volunteer study
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| Performance of device during use will be assessed by the incidence of flow-rate alarms on the haemofiltration pump during use. |
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.. |
| Through study completion, an average of 6 months |