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| Name | Class |
|---|---|
| Medfield Diagnostics | INDUSTRY |
| Chalmers University of Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemorrhagic stroke | Experimental | Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Interventions: Strokefinder MD100 measurement |
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| Ischemic stroke | Experimental | Patient group B is defined as patients that are diagnosed with ischemic stroke. Interventions: Strokefinder MD100 measurement |
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| Stroke mimics | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strokefinder MD100 measurement | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Any adverse events occurring within 24 hours from the measurement procedure(s) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikael Elam, PhD, MD | Contact | +46(0)70-940 10 42 | mikael.elam@neuro.gu.se | |
| Stefan J Candefjord, PhD | Contact | +46(0)73-382 15 37 | stefan.candefjord@chalmers.se |
| Name | Affiliation | Role |
|---|---|---|
| Mikael Elam, PhD, MD | Sahlgrenska University Hospital, Department of Clinical Neurophysiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital, Stroke Unit | Recruiting | Gothenburg | Västra Götaland County | 413 45 | Sweden |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Within 24 hours |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |