<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786536</url>
  </required_header>
  <id_info>
    <org_study_id>MSV_2018/01</org_study_id>
    <nct_id>NCT03786536</nct_id>
  </id_info>
  <brief_title>Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System</brief_title>
  <official_title>Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MediSieve Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MediSieve Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single centre, prospective, non-randomised healthy volunteer study to be undertaken&#xD;
      at University College Hospital London.&#xD;
&#xD;
      The study will be used to demonstrate the safe use of the MediSieve blood filtration system&#xD;
      in healthy volunteers prior to undertaking clinical trials on patients with relevant&#xD;
      pathologies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Healthy volunteer study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events.</measure>
    <time_frame>During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance of device during use. Time required for the user to set up and shut down the haemofiltration pump..</measure>
    <time_frame>Through study completion, an average of 6 months...</time_frame>
    <description>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..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of device during use will be assessed by the incidence of flow-rate alarms on the haemofiltration pump during use.</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>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..</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Haemofiltration</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All volunteers will receive the same treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MediSieve Magnetic Haemofiltration System</intervention_name>
    <description>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.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy volunteers who meet the following criteria will be considered eligible for the&#xD;
        study:&#xD;
&#xD;
          1. Male or female, at least 18 and ≤30 years of age;&#xD;
&#xD;
          2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Volunteers who meet the following criteria will NOT be eligible for the study:&#xD;
&#xD;
          1. Aged &lt;18 years of age;&#xD;
&#xD;
          2. Aged &gt;30 years of age;&#xD;
&#xD;
          3. Pregnant or lactating females;&#xD;
&#xD;
          4. Individuals &lt; 50kg&#xD;
&#xD;
          5. Individuals with an Hb blood level below 115 g/L&#xD;
&#xD;
          6. Individuals with coagulopathies or under medication that affects normal blood&#xD;
             coagulation profile, including COCP in females;&#xD;
&#xD;
          7. Individuals with a previous history of heparin-induced thrombocytopenia;&#xD;
&#xD;
          8. Individuals with known allergy to heparin;&#xD;
&#xD;
          9. Individuals with acute or chronic concomitant conditions; such as diabetes,&#xD;
             hypertension, autoimmune disease requiring on going therapy&#xD;
&#xD;
         10. Individuals with history of cancer in the last 5 years;(excluding localised skin&#xD;
             cancer or CIS)&#xD;
&#xD;
         11. Individuals with haemoglobinopathy disease;&#xD;
&#xD;
         12. Concurrent participation in another experimental intervention or drug study;&#xD;
&#xD;
         13. Unwilling or unable to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristina Blanco Andujar, PhD</last_name>
    <role>Study Director</role>
    <affiliation>MediSieve Limited</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cristina Blanco Andujar, PhD</last_name>
    <phone>+44 (0)7533 707796</phone>
    <email>info@medisieve.co.uk</email>
  </overall_contact>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786536
org study id: MSV_2018/01
nct id: NCT03786536
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Healthy volunteer study
primary purpose: Treatment
masking: None (Open Label)
measure: 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
description: 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
measure: 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...
description: 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..
measure: 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
description: 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..
arm group label: Treatment
arm group type: Experimental
description: All volunteers will receive the same treatment
intervention type: Device
intervention name: MediSieve Magnetic Haemofiltration System
description: 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.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cristina Blanco Andujar, PhD
role: Study Director
affiliation: MediSieve Limited
last name: Cristina Blanco Andujar, PhD
phone: +44 (0)7533 707796
email: info@medisieve.co.uk
responsible party type: Sponsor
sharing ipd: Undecided