Microwave Imaging in NeuroTrauma (MINT)

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.

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 Overview

• Status: Recruiting
• Conditions: Craniocerebral Trauma
• Intervention / Treatment: Device: MD100

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jack Barrett, BSc; Phone Number: 07871632555; Email: jack.barrett@secamb.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • King's College Hospital NHS FT
    • Contact: Malcolm Tunnicliff, MBBS
  • London, United Kingdom
    • Not yet recruiting
    • St George's Hospital NHS FT
    • Contact: Phil Moss

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Head injury patients presenting to the emergency department

Description

Inclusion Criteria:

• Patients 18 and over.
• Blunt head trauma
• The patient has had a CT head scan

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: MD100; 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.
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	Device: MD100; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the MD100	The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient.	One year

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: St George's University Hospitals NHS Foundation Trust; Air Ambulance Charity Kent, Surrey, Sussex; Medfield Diagnostics AB
• Investigators: Study Director: Malcom Tunnicliff, MBBS, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Head injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: 223018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No