None listed
Conditions
Brief summary
EMVision’s EMView study is a 3 stage, multicentre, study of the EMVision Gen 1 Brain Scanner to collect clinical data for hardware verification and software advancement for the imaging of acute stroke. The imaging software, once finalised, will be able to differentiate between stroke/no stroke, classify stroke as either haemorrhagic or ischaemic and localise the stroke event to a specific quadrant of the brain. The first stage of the study will gather data from 30 healthy participants, to establish an age-matched baseline against the target stroke patient population for ‘healthy brain’/no stroke. The second stage will gather data on 150 patients presenting to hospital emergency with symptoms suspected to be stroke, including a minimum of 15 haemorrhagic stroke, 15 ischaemic stroke, 10 stroke mimics with migraine, 10 stroke mimics with seizure and other stroke mimics. Data from the second stage will be used to estimate the final sample size necessary to advance the software algorithms to clinically useful performance levels. The third stage will gather data on up to 30 patients presenting to hospital emergency with symptoms suspected to be stroke and who are confirmed to have had a haemorrhagic stroke. Due to the nature of streamlined code-stroke protocols and timing of diagnosis and EMVision scan, other patients who present to hospital with suspected stroke will continue to be recruited until the haemorrhagic stroke group minimum target is met. The data from all stages of the study will allow the EMVision to finalise software algorithms that identify, classify and localise stroke. It is anticipated that EMView Study will enroll approximately 320 patients with stroke and stroke mimics in the second and third stages of the study.
Interventions
Stage 1 (Healthy Participants): After written informed consent has been acquired a physical examination will be performed followed by confirmation of the inclusion/exclusion criteria. After participant enrollment an MRI and the microwave signal will be obtained. Analysis of data for software development will be performed by comparing the microwave signal with the MRI as ground truth.
Stage 2/3: This stage will enroll participants with clinical signs of stroke in the acute phase (< 24 hours fr
Stage 1 (Healthy Participants): After written informed consent has been acquired a physical examination will be performed followed by confirmation of the inclusion/exclusion criteria. After participant enrollment an MRI and the microwave signal will be obtained. Analysis of data for software development will be performed by comparing the microwave signal with the MRI as ground truth. Stage 2/3: This stage will enroll participants with clinical signs of stroke in the acute phase (< 24 hours from onset of symptoms) admitted for CT scan. The inclusion/exclusion criteria will be assessed and if the participant is confirmed to be suitable for the trial, the participant will be asked to consent. If the answer is affirmative, the microwave scan will be performed. The procedure will take less than 15 minutes (the duration of the actual measurements is < 1 minute) and will not interfere with the patient's standard of care in the Emergency Department. For confirmed stroke patients, all follow-up standard of care CT/MRI scans will have a follow-up microwave scan up to 28 days from onset of symptoms or discharge. Analysis of data for software development will be performed by comparing the microwave signal with the CT/MRI as ground truth. CP2 Scanning Procedure: each CP2 scanning event involves two brain scans. The participant will be placed in prone position on an exam bed. The fiducial marker will be positioned above participants nose bridge and centered between the eyes. A disposable surgical cap will be placed on the participants head. Two staff members will be needed to operate the scanner – one person to ensure the fit and positioning of headset is correct and operate the machine, the other person to support the participants head and neck during placement of the headset. Once the participants positioning is correct, the membrane in the headset will be filled with a specific coupling medium to allow the headset to conform around the participants head. The membrane is made of silicone and will feel cool to the participant. Once the headset membrane is filled, the device will automatically begin first scan. Participants must remain very still during the scanning procedure. After the 1st scan is completed, the position of headset is adjusted and a 2nd scan is completed. After completion of the two CP2 scans, the headset membrane will deflate, and the headset, fiducial marker and surgical cap are removed. CP2 Scan Duration: The entire set up and scanning process including fitting of the headset will take less than 15 minutes. Actual scan time is < 30 seconds per scan. CP2 Scan Operators: After device user training has been undertaken for each expected operator of the device, study doctors which may include emergency room doctors, ICU doctors and study assigned registered nurses, will be delegated by the principal investigator to perform the CP2 brain scan procedure.
Sponsors
EMVision Medical Devices Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Arm A 1. Adults greater than or equal to 18 years of age. 2. Ability to provided informed consent 3. Head size deemed suitable for scanning with the EMVision Gen 1 Brain Scanner. Arms B-F 1. Adults greater than or equal to 18 years of age. 2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 24 hours of symptom onset 3. The use of the EMVision Gen 1 Brain Scanner will not delay the treatment of the participant 4. CT brain imaging following clinical evaluation in Emergency Department per standard of care 5. Ability to provide informed consent. Participants will provide written informed consent. Where this is not possible, consent from a legal authorized representative will be obtained. 6. Head size deemed suitable for scanning with the EMVision Gen 1 Brain Scanner.
Exclusion criteria
Arm A 1. History of neurological conditions (i.e., tumour, prior stroke, trauma etc) 2. Pregnant or breast feeding 3. Clinical signs or symptoms of stroke or other neurological conditions 4. Contraindication to neuroimaging, such conditions that prohibits MRI. 5. Presence of any implanted electro-stimulating devices in the head and neck. 6. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh etc (Note that small metallic objects, such an aneurysm coils etc, are acceptable) 7. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device 8. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries etc). 9. Is unable to lie still for the duration of the scan. 10. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment. Arms B-F 1. Has received treatment for current (suspected) stroke event prior to initial CT scan AND EMVision Gen 1 Brain Scanner scan. 2. Pregnant or breast feeding 3. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography. 4. Presence of any implanted electro-stimulating devices in the head and neck 5. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh etc. (Note that small metallic objects, such an aneurysm coils etc, are acceptable) 6. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device. 7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries etc). 8. Is unable to lie still for the duration of the scan. 9. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment.
Outcome results
None listed