Microwave Imaging in NeuroTrauma

Craniocerebral Trauma Clinical Trial

— MINT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960279
• Other study ID #: 223018
• Status: Recruiting
• Start date: July 20, 2021
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: King's College Hospital NHS Trust
• Contact: Jack Barrett, BSc
• Phone: 07871632555
• Email: jack.barrett[@]secamb.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Craniocerebral Trauma

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS FT	London
United Kingdom	St George's Hospital NHS FT	London

Sponsors (4)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Air Ambulance Charity Kent, Surrey, Sussex, Medfield Diagnostics AB, St George's University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the MD100	The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient.	One year