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EMVision First Responder Brain Scanner in the Melbourne Mobile Stroke Unit (Stage 1)

Workflow Assessment and Usability of the EMVision First Responder Brain Scanner in the Melbourne Mobile Stroke Unit

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001152415
Enrollment
10
Registered
2025-10-21
Start date
2025-11-01
Completion date
2026-01-01
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial is the first stage of a staged workflow assessment and data collection study of the EMVision First Responder Brain Scanner for patients suspected of suffering from an acute stroke. This stage of the study is a usability and workflow assessment used qualify the impact of the EMVision First Responder Brain Scanner procedures on the MSU workflow. This study collects EMVision brain scans including workflow metrics generated from scan procedures timestamps. This study hypothesises that the impact of the EMVision First Responder Brain Scanner procedure does not impact the emergency stroke MSU workflow.

Interventions

This trial is the first stage of a two stage study for the development of the pre-hospital EMVision First Responder Brain Scanner in the Melbourne Mobile Stroke Unit (MSU), intending to enrol a total of 10 participants. This study aims to assess the the MSU workflow with the inclusion of a EMVision First Responder Brain Scan procedure. Participants attended to by the MSU suspected of suffering from a suspected stroke will receive an EMVision First Responder brain scan. This brain scan measures

This trial is the first stage of a two stage study for the development of the pre-hospital EMVision First Responder Brain Scanner in the Melbourne Mobile Stroke Unit (MSU), intending to enrol a total of 10 participants. This study aims to assess the the MSU workflow with the inclusion of a EMVision First Responder Brain Scan procedure. Participants attended to by the MSU suspected of suffering from a suspected stroke will receive an EMVision First Responder brain scan. This brain scan measures the dielectric properties of the brain using non-invasive, non-ionising, low-energy, electromagnetic pulses. During an EMVision First Responder brain scan procedure, the EMVision First Responder Brain Scanner is brought to a participant lying supine on a comfortable flat surface (i.e., stretcher, bed). A headset housing an array of antennae is placed on the head, where the headset membrane inflates with a coupling fluid to conform to the shape of the head during which the scans take place. Participation in this study consists of a single visit taking place at the scene of MSU attendance and consists of a single brief scan procedure (typically under six minutes) conducted by a qualified physician, nurse or paramedic. Study participation is considered complete upon the conclusion of the brain scan. No additional study procedures are required of the participant following the initial brain scan. Personnel responsible for conducting scans will receive two hours of face-to-face training with EMVision trainers approximately one week prior to enrolment of the first participant. All scan data is reviewed by EMVision engineers to verify scanning procedures are conducted to an appropriate standard.

Sponsors

EMVision
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults >= 18 years of age. Patients attended to by a Mobile Stroke Unit. Head size deemed suitable to fit the device. The use of the EMVision First Responder Brain Scanner will not delay the assessment or treatment of the patient.

Exclusion criteria

Contraindications to the EMVision First Responder Brain Scanner procedure. Unable to lie still for the duration of the expected scan time. Any other medical or logistical contraindication at the discretion of the MSU team.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026