## Protocol Section
### Identification Module
**NCT ID:** NCT05960279

**Acronym:** MINT

**Brief Title:** Microwave Imaging in NeuroTrauma

**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

#### Organization Study ID Info
**ID:** 223018
#### Organization
**Class:** OTHER
**Full Name:** King's College Hospital NHS Trust
### Status Module
#### Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-25

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-07-20

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2023-07-25
**Type:** ACTUAL
**Study First Submit Date:** 2023-07-12
**Study First Submit QC Date:** 2023-07-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Air Ambulance Charity Kent, Surrey, Sussex

**Class:** OTHER

**Name:** St George's University Hospitals NHS Foundation Trust

**Class:** UNKNOWN

**Name:** Medfield Diagnostics AB

#### Lead Sponsor

**Class:** OTHER

**Name:** King's College Hospital NHS Trust

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Craniocerebral Trauma

**Keywords:**

- Head injury

- Traumatic brain injury

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: MD100

**Label:** Training group

#### Arm Group 2

**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

**Intervention Names:**

- Device: MD100

**Label:** Testing group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Testing group

- Training group

**Description:** 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.

**Name:** MD100

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Accuracy of the MD100

**Time Frame:** One year

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Head injury patients presenting to the emergency department

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jack.barrett@secamb.nhs.uk

**Name:** Jack Barrett, BSc

**Phone:** 07871632555

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Malcolm Tunnicliff, MBBS

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** King's College Hospital NHS FT

**Status:** RECRUITING

**Location 2:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Phil Moss

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** St George's Hospital NHS FT

**Status:** NOT_YET_RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** King's College Hospital NHS Trust

**Name:** Malcom Tunnicliff, MBBS

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: HIGH

- As Found: Craniocerebral Trauma

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006259

- Term: Craniocerebral Trauma

### Misc Info Module

- Version Holder: 2024-05-24
