Overview
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.
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.
Eligibility
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 investigators judgment
- Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrolment