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Microwave Imaging in NeuroTrauma

NCT05960279 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-07-25

No results posted yet for this study

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.

Conditions

  • Craniocerebral Trauma

Interventions

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.

Sponsors & Collaborators

  • Air Ambulance Charity Kent, Surrey, Sussex

    collaborator UNKNOWN

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Medfield Diagnostics AB

    collaborator UNKNOWN

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Malcom Tunnicliff, MBBS · King's College Hospital NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960279 on ClinicalTrials.gov