Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase

Recruiting

Phase N/A Results N/A

Trial Description

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. Follow-up microwave measurements will be performed after the acute phase. The study assesses the diagnostic capability and safety of Strokefinder MD100.

Detailed Description

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The investigator will assess and control the inclusion/exclusion criteria. If the patient is confirmed to be suitable for the trial, the patient is asked to give oral informed consent. If the answer is affirmative the microwave measurement will be performed. The procedure will take less than five minutes (the duration of the actual measurement procedure is 1.5 minutes) and will not interfere with the patient's standard of care during the hospital stay. Written informed consent is acquired by the investigator, as soon as possible after the acute phase of care is completed. Follow-up microwave measurements will be performed after the acute phase.
The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation (LOOCV) method with the CT diagnosis as ground truth.
Safety will be evaluated throughout the trial, and a safety follow-up will be performed by the investigator 24 hours after the last microwave measurement. No further follow-up of patients is planned.

Conditions

Interventions

  • Strokefinder MD100 prehospital measurement Device
    Intervention Desc: A prehospital microwave measurement will be performed with the patient lying on the ambulance stretcher or another suitable surface.
    ARM 1: Kind: Experimental
    Label: Hemorrhagic stroke
    Description: Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement; Strokefinder MD100 hospital measurement
    ARM 2: Kind: Experimental
    Label: Ischemic stroke
    Description: Patient group B is defined as patients that are diagnosed with ischemic stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement; Strokefinder MD100 hospital measurement
    ARM 3: Kind: Experimental
    Label: Stroke mimics
    Description: Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement
  • Strokefinder MD100 hospital measurement Device
    Intervention Desc: A follow-up microwave measurement will be performed at the hospital in conjunction with a Computed Tomography (CT) scan, if this is performed as part of the standard of care within 48 hours of stroke onset.
    ARM 1: Kind: Experimental
    Label: Hemorrhagic stroke
    Description: Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement; Strokefinder MD100 hospital measurement
    ARM 2: Kind: Experimental
    Label: Ischemic stroke
    Description: Patient group B is defined as patients that are diagnosed with ischemic stroke. Note that the diagnosis is not known in the prehospital phase of the study. Interventions: Strokefinder MD100 prehospital measurement; Strokefinder MD100 hospital measurement
  • Strokefinder MD100 measurement Device
    Intervention Desc: A microwave measurement will be performed with the patient lying in the hospital bed or another suitable surface. Follow-up microwave measurements will be performed after the acute phase.
    ARM 1: Kind: Experimental
    Label: Hemorrhagic stroke
    Description: Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Interventions: Strokefinder MD100 measurement
    ARM 2: Kind: Experimental
    Label: Ischemic stroke
    Description: Patient group B is defined as patients that are diagnosed with ischemic stroke. Interventions: Strokefinder MD100 measurement
    ARM 3: Kind: Experimental
    Label: Stroke mimics
    Description: Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. Interventions: Strokefinder MD100 measurement

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient groups A and B in the prehospital setting, using the leave-one-out cross validation (LOOCV) method The diagnostic procedure will take less than 5 minutes No
Secondary The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B in the prehospital setting, using the LOOCV method The diagnostic procedure will take less than 5 minutes No
Secondary The diagnostic ability as measured by the AUC of the device for patient groups A and B in the hospital setting, using the LOOCV method The diagnostic procedure will take less than 5 minutes No
Secondary The proportion of patients that the device will deliver adequate measurement data for in the prehospital setting The diagnostic procedure will take less than 5 minutes No
Secondary Mean time (± standard deviation) needed from arrival at patient side to completion of measurement procedure in the prehospital setting The diagnostic procedure will take less than 5 minutes No
Secondary Mean time (± standard deviation) needed to complete the measurement procedure (prehospital and hospital settings) The diagnostic procedure will take less than 5 minutes No
Secondary Any adverse events occurring within 24 hours from the measurement procedure(s) Within 24 hours Yes
Primary The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient group A vs. group B, using the leave-one-out cross validation (LOOCV) method The diagnostic procedure will take less than 5 minutes
Secondary The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method The diagnostic procedure will take less than 5 minutes

Sponsors