None listed
Conditions
Brief summary
This study is a continuous innovation study of the EMVision emu™ brain scanner for patients suspected of suffering from an acute stroke or intracranial haemorrhage for algorithm development purposes and indication expansion to traumatic brain injuries. This study collects EMVision brain scans and radiological scans from patients receiving brain imaging as part of their routine care. Scans are anonymised and enter the EMVision database for advancing and extending software algorithms. This study hypothesises that an expanded acute brain injury dataset can improve the diagnostic performance of the emu™ brain scanner and extend utility to patients suspected of intracranial haemorrhage following traumatic brain injury.
Interventions
This study is a continued innovation study for the development of additional software features for the emu™ Brain Scanner. Participants who present to the hospital suspected of suffering from a suspected stroke or intracranial haemorrhage will receive an emu™ brain scan. emu™ device brain scans measure the dielectric properties of the brain using non-invasive, non-ionising, low-energy, electromagnetic pulses. During an emu™ brain scan procedure, the emu™ is brought bedside to a participant lying supine on a hospital 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 in the hospital and consists of a single brief scan procedure (typically under six minutes) conducted by a qualified nurse or physician. Study participation is considered complete upon positive radiological confirmation of the presenting condition, patient discharge, or 28 days, whichever is earliest. No procedures are required of the participant following the initial emu™ brain scan. Nurses and physicians responsible for conducting scans will receive two hours of face-to-face training or refresher 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
Study design
Eligibility
Inclusion criteria
Presenting to hospital with acute suspected stroke or intracranial haemorrhage (ICH) and within 12 hours of symptom onset. The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient. CT or MRI brain imaging planned or received following clinical evaluation in Emergency Department per standard of care. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner.
Exclusion criteria
Has received treatment for current acute presentation event prior to initial CT/MRI scan or EMVision emu™ Brain Scanner scan (such as thrombolysis) Contraindication to neuroimaging. Known presence of medical implantation in the head. Known neck conditions/injuries. Unable to lie still for the duration of the scan. Pregnant or breastfeeding. Any other condition or symptoms preventing the participant from entering the study, according to the investigator’s judgment.