Microwave Imaging in NeuroTrauma

Recruiting

• Conditions: Craniocerebral Trauma
• Interventions: Device: MD100

• Registration Number: NCT05960279
• Lead Sponsor: King's College Hospital NHS Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Accuracy of the MD100	One year	The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient.

Trial Locations

Locations (2)

King's College Hospital NHS FT; 🇬🇧 London, United Kingdom

St George's Hospital NHS FT; 🇬🇧 London, United Kingdom