Clinical trial NCT06999122: Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients
Official title: Multi-Center, Prospective, Consecutive, Paired Diagnosis, Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Hemorrhagic Stroke
Lead sponsor: EMVision Medical Devices Ltd
Sponsor class: NETWORK
First posted: 2025-05-31
Enrollment: 300
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 subjects across two study arms

Brief summary: The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available.

EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.

Detailed description: This clinical investigation is a paired diagnosis, diagnostic performance study intended to quantify the accuracy of the emu™ Brain Scanner's diagnostic output in comparison to current gold-standard practices including multi-modal neuroimaging by CT and/or MRI.

Any adult with neurological deficit suspected to be stroke presenting to the investigational site's emergency department shall be considered as potentially eligible for the study. Potential participant's eligibility for the study is determined via screening evaluation which includes a review of available demographic and medical history information against the study's inclusion and exclusion criteria, as well as a head size assessment using provided gauges to confirm that their head would fit within the emu™ Brain Scanner. If the screening evaluation finds that the participant is eligible for the study then the investigator proceeds with the informed consent process. This activity occurs in parallel with the investigational site's standard practices for stroke patient management, ensuring no delay in these patients' care.

Regardless of study participation, participants will receive the complete standard of care diagnostic workflow in accordance with applicable national and international guidelines, as well as practices established at the investigational site. The standard of care diagnostic workflow is centered around acute baseline multi-modal CT imaging (and in some instances MRI). Directly following or before this imaging, and without delaying subsequent treatment, a scan is completed with the emu™ Brain Scanner to allow timely coordination between the investigational emu™ Brain Scan result and the reference standard CT/MRI imaging. If the attending physician perceives any potential risk of delaying treatment of the patient then that patient is strictly exclude from the study, entirely at the attending physician's discretion.

A central adjudicating ground truth diagnosis panel is formed of experts in the area of stroke diagnosis and reviews all diagnostic information gathered by the investigational site as per the site's standard of care diagnostic workflow. The ground truth diagnosis panel is blinded to the output from the emu™ Brain Scanner and defines the 'ground truth' or 'reference standard' diagnosis for each patient to ensure accuracy and consistency. Integral to the ground truth diagnosis panel's consideration is the assessment by the core imaging lab, who similarly review all imaging provided by the investigational sites to ensure consistent input to the ground truth expert panel.

The result of the emu™ Brain Scan is compared to the ground truth diagnosis by a biostatistician to determine the accuracy of the emu™ Brain Scanner's diagnostic output (in terms of sensitivity and specificity) with the first output evaluated being intracranial haemorrhage detection in suspected stroke patients. The biostatistician then performs all statistical analyses against the study objectives in accordance with the Statistical Analysis Plan.

Eligibility criteria: Inclusion Criteria:

1. Adults ≥22 years of age
2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 hours of symptom onset
3. The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient
4. CT or MRI brain imaging following clinical evaluation in Emergency Department per standard of care
5. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -

Exclusion Criteria:

1. Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
2. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
3. Presence of any implanted electro-stimulating devices in the head and neck
4. Presence of any metallic implants in the cranial vault or surrounding bones/tissue (Note that metallic objects distant from the scan area, such as dental implants, nasal piercing etc., are acceptable)
5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
6. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
7. Unable to lie still for the duration of the scan
8. Pregnant or breastfeeding
9. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -

Primary outcomes:
measure: Demonstrate haemorrhage detection sensitivity >80% and specificity >80%
timeFrame: <30 minutes from acute baseline CT/MRI
Secondary outcomes:
measure: Demonstrate the time to complete an emu™ Brain Scan is <15 minutes
timeFrame: <30 minutes from acute baseline CT/MRI
measure: Evaluate safety of the device
timeFrame: <30 minutes from acute baseline CT/MRI
measure: Evaluate usability of the device
timeFrame: <30 minutes from acute baseline CT/MRI
measure: Evaluate device deficiencies
timeFrame: <30 minutes from acute baseline CT/MRI
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Jacksonville
state: Florida
city: Houston
country: United States
facility: UTHealth
state: Texas
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Associate Professor of Neurosurgery and Radiology Director of Neurointerventional Spine Site Director Cerebrovascular Services Mount Sinai Queens Co-director Neuroendovascular Surgery Fellowship Department of Neurosurgery Mount Sinai Health System
name: Reade De Leacy, MBBS(Hons) FRANZCR
role: PRINCIPAL_INVESTIGATOR
affiliation: Melbourne Health
name: Angela Dos Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: