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Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03786536
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
MediSieve Limited

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Healthy volunteer study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: Treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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..

  2. 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..



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy volunteers who meet the following criteria will be considered eligible for the study:

  1. Male or female, at least 18 and ≤30 years of age;
  2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

Volunteers who meet the following criteria will NOT be eligible for the study:

  1. Aged <18 years of age;
  2. Aged >30 years of age;
  3. Pregnant or lactating females;
  4. Individuals < 50kg
  5. Individuals with an Hb blood level below 115 g/L
  6. Individuals with coagulopathies or under medication that affects normal blood coagulation profile, including COCP in females;
  7. Individuals with a previous history of heparin-induced thrombocytopenia;
  8. Individuals with known allergy to heparin;
  9. Individuals with acute or chronic concomitant conditions; such as diabetes, hypertension, autoimmune disease requiring on going therapy
  10. Individuals with history of cancer in the last 5 years;(excluding localised skin cancer or CIS)
  11. Individuals with haemoglobinopathy disease;
  12. Concurrent participation in another experimental intervention or drug study;
  13. Unwilling or unable to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786536


Contacts
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Contact: Cristina Blanco Andujar, PhD +44 (0)7533 707796 cristina@medisieve.co.uk

Sponsors and Collaborators
MediSieve Limited
University College London Hospitals
Investigators
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Study Director: Cristina Blanco Andujar, PhD MediSieve Limited

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Responsible Party: MediSieve Limited
ClinicalTrials.gov Identifier: NCT03786536     History of Changes
Other Study ID Numbers: MSV_2018/01
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No