An interventional study of Strokefinder MD100 measurement in Stroke, sponsored by Mikael Elam. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.
Sponsored by Mikael Elam · 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. Follow-up microwave measurements will be performed after the acute phase. 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. 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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 500 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Mikael Elam as lead sponsor.
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Exclusion Criteria:
Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Interventions: Strokefinder MD100 measurement
Device: Strokefinder MD100 measurement
Patient group B is defined as patients that are diagnosed with ischemic stroke. Interventions: Strokefinder MD100 measurement
Device: Strokefinder MD100 measurement
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
Device: Strokefinder MD100 measurement
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.
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
Time frame: The diagnostic procedure will take less than 5 minutes
The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method
Time frame: The diagnostic procedure will take less than 5 minutes
Any adverse events occurring within 24 hours from the measurement procedure(s)
Time frame: Within 24 hours
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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