An interventional study of Hemorrhagic stroke group (group A) and Ischemic stroke group (group B) in Stroke, Acute and Intracerebral Hemorrhage, sponsored by Helse Stavanger HF. Status unknown at 4 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Diagnostic
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 study assesses the diagnostic capability and safety of Strokefinder MD100.
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 500 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Helse Stavanger HF is the lead sponsor of 97 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Patient group A is defined as patients that are diagnosed with hemorrhagic stroke.
Diagnostic Test: Hemorrhagic stroke group (group A)
Patient group B is defined as patients that are diagnosed with ischemic stroke.
Diagnostic Test: Ischemic stroke group (group B)
Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke.
Diagnostic Test: Stroke mimic group (group C)
Group A: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.
Group B: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.
Group C: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.
To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting
The diagnostic ability as measured by the area under the curve of the device for patient groups (group C vs. groups A + B) using the LOOCV method
Time frame: Baseline
Adverse events within 24 hours
Any adverse events occurring within 24 hours from the measurement procedure(s)
Time frame: Baseline to 24 hours
To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics
To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics from patients with stroke (hemorrhagic stroke and ischemic stroke) in the prehospital and hospital setting
Time frame: Baseline
To evaluate the delivery of adequate measurement data from the device
To evaluate the delivery of adequate measurement data from the device in the prehospital and hospital setting
Time frame: Baseline
To evaluate the amount of time needed to perform the measurement procedures
To evaluate the amount of time needed to perform the measurement procedures in the prehospital and hospital settings
Time frame: Basline
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Feb 2022, 48 months after the start.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 48 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Helse Stavanger HF