Craniocerebral TraumaMINTNCT05960279
Microwave Imaging in NeuroTrauma
An observational study of Craniocerebral Trauma, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
Trial summary
The study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head. The MD100 is a microwave-based head scanner, developed for the purpose of detecting strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniocerebral Trauma
- What is being tested?
- MD100
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Jul 2021to Jan 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Head injury patients presenting to the emergency department
Who may be able to join
- Patients 18 and over.
- Blunt head trauma
- The patient has had a CT head scan
Who cannot join
- Patients with head injuries penetrating the skull
- Patients with radiologically confirmed cervical spine fracture
- Patients with radiologically confirmed depressed skull fracture and/or dislocation
- Patients with implanted metal in or around their skull (including titanium places and surgical staples)
- Confirmed pregnancy
- Per the investigator's judgement, any condition or symptoms preventing the patient from entering the trial.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
King's College Hospital NHS FT
London
Malcolm Tunnicliff, MBBS
- Not yet recruiting
St George's Hospital NHS FT
London
Phil Moss
About this study
Official title: Microwave Imaging in NeuroTrauma (MINT) - a Feasibility Study Investigating Whether Microwave-based Scanning Technology Can Detect an Intra-cranial Bleed in Adult Head Injury Patients
The study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head.
The MD100 is a microwave-based head scanner, developed for the purpose of detecting strokes. In clinical trials, it was noticed that the device performed better when the patient suffered a stroke due to a bleed. It was believed that this device had wider applications in trauma care.
Read more
The MD100 has demonstrated a very high level of accuracy in detecting bleeds in small clinical trials in the non-acute setting. The device is supported by software that determines the presence of a bleed.
This study will be set in the emergency department of major trauma centres. Patients that have sustained a head injury will be considered for enrollment into the study. Following a head CT scan, patients will be scanned by the MD100. The trial will run in two phases.
In phase one: the findings from the patient's head CT scan will be used to trial the device and teach the software what it is scanning. In phase two: The MD100 will be tested to see whether it can concur with the findings of the patient's CT scan, this will be used to determine the accuracy and reliability of the device.
- Conditions
- Craniocerebral Trauma
- Being tested
- MD100
- Keywords
- Head injury, Traumatic brain injury
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD100Device
The MD100 (Medfield Diagnostics, Gothenburg, Sweden) consists of 8 antennas and measurement electronics integrated into a single device; rechargeable ion batteries power the instrument. The radiation transmitted from the device equals approximately 1% of the radiation emitted from a mobile phone. The device is non-invasive and small enough that it can be moved around with ease.
The system transmits microwaves with an output of 0.2 milliWatts (mW) for less than 90 seconds. The power absorbed by the body is 100mW/kg which is a factor of 200 less than what is established by the existing safety standard for microwaves. A mobile phone output, by comparison, can be up to 250mW.
The patient's head is placed in the instrument during measurement while the patient is supine. The procedure takes, on average, 5 minutes to perform.
| Study group | Role | What they receive |
|---|---|---|
| Training group | The head CT findings from this patient group will be used to teach the MD100 how to interpret its scan of the patients. Receives: Device: MD100 | |
| Testing group | Once sufficient training data has been obtained, subsequent head CT findings from patients enrolled into the study will be used to test the accuracy of the MD100 Receives: Device: MD100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the MD100
The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start20 Jul 2021
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TraumaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Air Ambulance Charity Kent, Surrey, Sussex, St George's University Hospitals NHS Foundation Trust, Medfield Diagnostics
- Responsible party
- Sponsor
- Investigators
- Malcom Tunnicliff, MBBS, Study director, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960279
- Sponsor's protocol ID
- 223018
- Acronym
- MINT
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 25 Jul 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Imaging in NeuroTrauma (MINT) - a Feasibility Study Investigating Whether Microwave-based Scanning Technology Can Detect an Intra-cranial Bleed in Adult Head Injury Patients
- ClinicalTrials.gov ID
- NCT05960279
- Acronym / sponsor ID
- MINT / 223018
- Conditions
- Craniocerebral Trauma
- Keywords
- Head injury, Traumatic brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Air Ambulance Charity Kent, Surrey, Sussex, St George's University Hospitals NHS Foundation Trust, Medfield Diagnostics
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 25 Jul 2023 (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.
The study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head.
The MD100 is a microwave-based head scanner, developed for the purpose of detecting strokes. In clinical trials, it was noticed that the device performed better when the patient suffered a stroke due to a bleed. It was believed that this device had wider applications in trauma care.
The MD100 has demonstrated a very high level of accuracy in detecting bleeds in small clinical trials in the non-acute setting. The device is supported by software that determines the presence of a bleed.
This study will be set in the emergency department of major trauma centres. Patients that have sustained a head injury will be considered for enrollment into the study. Following a head CT scan, patients will be scanned by the MD100. The trial will run in two phases.
In phase one: the findings from the patient's head CT scan will be used to trial the device and teach the software what it is scanning. In phase two: The MD100 will be tested to see whether it can concur with the findings of the patient's CT scan, this will be used to determine the accuracy and reliability of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | – | Device: MD100The head CT findings from this patient group will be used to teach the MD100 how to interpret its scan of the patients. |
| Testing group | – | Device: MD100Once sufficient training data has been obtained, subsequent head CT findings from patients enrolled into the study will be used to test the accuracy of the MD100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head injury patients presenting to the emergency department
Key inclusion criteria (3 listed)
- Patients 18 and over.
- Blunt head trauma
- The patient has had a CT head scan
Key exclusion criteria (6 listed)
- Patients with head injuries penetrating the skull
- Patients with radiologically confirmed cervical spine fracture
- Patients with radiologically confirmed depressed skull fracture and/or dislocation
- Patients with implanted metal in or around their skull (including titanium places and surgical staples)
- Confirmed pregnancy
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 |
|---|---|---|
| MD100The MD100 (Medfield Diagnostics, Gothenburg, Sweden) consists of 8 antennas and measurement electronics integrated into a single device; rechargeable ion batteries power the instrument. The radiation transmitted from the device equals approximately 1% of the radiation emitted from a mobile phone. The device is non-invasive and small enough that it can be moved around with ease. The system transmits microwaves with an output of 0.2 milliWatts (mW) for less than 90 seconds. The power absorbed by the body is 100mW/kg which is a factor of 200 less than what is established by the existing safety standard for microwaves. A mobile phone output, by comparison, can be up to 250mW. The patient's head is placed in the instrument during measurement while the patient is supine. The procedure takes, on average, 5 minutes to perform. | Device | Testing group, Training group |
Primary outcome
Accuracy of the MD100
Time frame: One year
The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 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.
Malcom Tunnicliff, MBBS study director
King's College Hospital NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniocerebral Trauma, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
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 6 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack Barrett, BSc (07871632555, jack.barrett@secamb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the MD100 (time frame: One year). 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 25 Jul 2023.