Microwave Imaging in NeuroTrauma (MINT)

King's College Hospital NHS Trust

Status: Enrolling

Conditions: Craniocerebral Trauma

Treatments: Device: MD100

Study type: Observational

Funder types: Other

Identifiers

NCT05960279

223018

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Training group

Description:

The head CT findings from this patient group will be used to teach the MD100 how to interpret its scan of the patients.

Treatment:

Device: MD100

Testing group

Description:

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

Treatment:

Device: MD100