NCT05960279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3.5 years

First QC Date

July 12, 2023

Last Update Submit

July 21, 2023

Conditions

Craniocerebral Trauma

Keywords

Head injuryTraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the MD100

    The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient.

    One year

Study Arms (2)

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

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

Interventions

MD100DEVICE

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 groupTraining group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Head injury patients presenting to the emergency department

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King's College Hospital NHS FT

London, United Kingdom

RECRUITING

St George's Hospital NHS FT

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Malcom Tunnicliff, MBBS

    King's College Hospital NHS Trust

    STUDY DIRECTOR

Central Study Contacts

Jack Barrett, BSc

CONTACT

07871632555jack.barrett@secamb.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 25, 2023

Study Start

July 20, 2021

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations

GB(2)