Intracerebral Hemorrhage, Stroke, Acute
Conditions
Brief summary
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.
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. 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.
Interventions
DIAGNOSTIC_TESTHemorrhagic stroke group (group A)
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.
DIAGNOSTIC_TESTIschemic stroke group (group B)
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.
DIAGNOSTIC_TESTStroke mimic group (group C)
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.
Sponsors
Haukeland University Hospital
Equinor
Medfield Diagnostics
Nordlandssykehuset HF
Helse Stavanger HF
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with clinical signs of stroke * Patient should be ≥ 18 years of age * Patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase) * Signed Informed Consent Form (after acute phase)
Exclusion criteria
* Pregnant or nursing woman * Fertile woman where pregnancy cannot be excluded * Patient diagnosed with a condition associated with risk of poor protocol compliance * The diagnostic procedure is deemed to interfere with the standard of care * Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment * Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting | Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events within 24 hours | Baseline to 24 hours | Any adverse events occurring within 24 hours from the measurement procedure(s) |
| To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics | Baseline | 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 |
| To evaluate the delivery of adequate measurement data from the device | Baseline | To evaluate the delivery of adequate measurement data from the device in the prehospital and hospital setting |
| To evaluate the amount of time needed to perform the measurement procedures | Basline | To evaluate the amount of time needed to perform the measurement procedures in the prehospital and hospital settings |
Countries
Norway
Contacts
Primary ContactMartin Kurz, PhD
Outcome results
None listed