HaemofiltrationNCT03786536
Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System
A study testing MediSieve Magnetic Haemofiltration System in people with Haemofiltration, run by MediSieve Limited.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemofiltration
- What is being tested?
- MediSieve Magnetic Haemofiltration System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
About this study
Official title: Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
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.
- Conditions
- Haemofiltration
- Being tested
- MediSieve Magnetic Haemofiltration System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediSieve Magnetic Haemofiltration SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All volunteers will receive the same treatment Receives: Device: MediSieve Magnetic Haemofiltration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment
Secondary outcomes (2)
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..
Measured: Through study completion, an average of 6 months...
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..
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Jun 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Approval of specific study by UK MHRA not received. Study performed in different circumstances and with different clinical sites / partners.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemofiltrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy volunteer study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediSieve Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Cristina Blanco Andujar, PhD, Study director, MediSieve Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786536
- Sponsor's protocol ID
- MSV_2018/01
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03786536
- Acronym / sponsor ID
- MSV_2018/01
- Conditions
- Haemofiltration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Approval of specific study by UK MHRA not received. Study performed in different circumstances and with different clinical sites / partners.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MediSieve LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy volunteer study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: MediSieve Magnetic Haemofiltration SystemAll volunteers will receive the same treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MediSieve Magnetic Haemofiltration SystemThe 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. | Device | Treatment |
Primary outcome
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
2 secondary outcomes
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...
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Blanco Andujar, PhD study director
MediSieve Limited
Questions about this trial
What is this clinical trial studying?
A study testing MediSieve Magnetic Haemofiltration System in people with Haemofiltration, run by MediSieve Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.