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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| Equinor | UNKNOWN |
| Medfield Diagnostics | INDUSTRY |
| Nordlandssykehuset HF |
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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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemorrhagic stroke group (group A) | Experimental | Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. |
|
| Ischemic stroke group (group B) | Experimental | Patient group B is defined as patients that are diagnosed with ischemic stroke. |
|
| Stroke mimic group (group C) | Experimental | Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemorrhagic stroke group (group A) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events within 24 hours | Any adverse events occurring within 24 hours from the measurement procedure(s) | Baseline to 24 hours |
| To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Kurz, PhD | Contact | 47246847 | martin.kurz@sus.no |
| Name | Affiliation | Role |
|---|---|---|
| Martin Kurz, PhD | Helse Stavanger HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | Norway |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
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| Ischemic stroke group (group B) | Diagnostic Test | 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. |
|
| Stroke mimic group (group C) | Diagnostic Test | 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 differentiate patients with stroke mimics from patients with stroke (hemorrhagic stroke and ischemic stroke) in the prehospital and hospital setting
| 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 | 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 | Basline |
| Norlandsykehuset HF | Not yet recruiting | Bodø | Norway |
|
| Statoil As | Recruiting | Stavanger | 4017 | Norway |
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| Stavanger University Hospital | Recruiting | Stavanger | 4017 | Norway |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |