Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
EMVision Medical Devices Ltd
Study ID
NCT06999122
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brain Scan — DIAGNOSTIC_TEST
    The EMVision emu™ Brain Scanner is a device system which scans the human brain using radiofrequency techniques. The emu™ headset is placed on the head of a patient, enabling ultra-high frequency radio wave (also commonly referred to as microwave) signal propagation into the patient's head. The radio-waves reflect from and transmit through the tissue boundaries and are detected by the receiver antennae within the headset. The transceivers operate at very low-level signals in accordance with national and international safety thresholds. The scattered signals carry information on the scanned tissues.

Study Details

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.

Key Dates

Start date
Mar 26, 2025
Status verified
May 2025
Primary completion
Nov 1, 2026
Completion
Nov 28, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Intracranial Haemorrhage Group A
  • Arm: Other Group B
    Group B includes all patients enrolled in the study ultimately diagnosed with a condition other than intracranial haemorrhage, including ischaemic stroke, transient ischaemic attack, or any of a variety of stroke mimicking conditions.

Primary Outcome Measure

Demonstrate haemorrhage detection sensitivity >80% and specificity >80% [ Time Frame: <30 minutes from acute baseline CT/MRI ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo JacksonvilleJacksonvilleFlorida32224
Ewa Szymkiewicz
[email protected]
904-953-3219
William Freeman, PhD (PRINCIPAL_INVESTIGATOR)
UTHealthHoustonTexas77030
Glenda Torres
[email protected]
713-500-6153
Aaron Gusdon, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Mayo Jacksonville· Jacksonville, FLUTHealth· Houston, TX

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