Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase

Recruiting

Phase N/A Results N/A

Update History

19 May '17 acronym not implemented.
Trial name was updated.
New
Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase
The Summary of Purpose was updated.
New
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.
Old
This is a prospective, open, multicenter study that will enroll patients with clinical signs of stroke in the prehospital setting. A follow-up microwave measurement will be performed by the hospital investigator for the patients admitted to the Stroke Unit at Sahlgrenska University Hospital in conjunction with a CT scan, if this is performed as part of the standard of care within 48 hours of stroke onset. The study assesses the diagnostic capability, measurement performance, safety and usability of Strokefinder MD100 in a prehospital environment.
The description was updated.
New
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.
Old
This is a prospective, open, multicenter study that will enroll patients with clinical signs of stroke in the prehospital setting. When the dispatch center (in Sweden SOS Alarm 112) decides to dispatch an ambulance with highest priority (1, with lights/sirens active) for a suspected case of stroke, a research nurse staffed single responder vehicle equipped with Strokefinder MD100 will be dispatched to the scene, if deemed possible to reach the site ahead of the first ambulance. The research nurse will evaluate if the patient fulfills all of the inclusion criteria and none of the exclusion criteria, on delegation from the prehospital investigator. If confirmed to be suitable for the study the patient is asked about verbal informed consent. If the answer is affirmative the microwave measurement will be performed with the patient lying on the ambulance stretcher or another suitable surface. The procedure will take less than five minutes (the duration of the actual measurement is < 1 minute) and will not interfere with the patient's standard of care during transport or at the receiving hospital. Written informed consent is acquired by the hospital investigator, as soon as possible after the acute phase of care is completed. A follow-up microwave measurement will be performed by the hospital investigator for the patients admitted to the Stroke Unit at Sahlgrenska University Hospital/Sahlgrenska in conjunction with a Computed Tomography (CT) scan, if this is performed as part of the standard of care within 48 hours of stroke onset. 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. The time from arrival at patient side to completion of measurement procedure, and the duration for the measurement procedure itself, will be measured. Safety will be evaluated throughout the study, and a safety follow-up will be performed by the hospital investigator 24 hours after the last microwave measurement is finalized. No further follow-up of patients is planned.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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Inclusion Criteria: - Patient should be ≥ 18 years of age - Patient has clinical signs of stroke - 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
Old
Inclusion Criteria: - Patient should be ≥ 18 years of age - Patient has clinical signs of stroke - Patient/close relative confirms orally that the patient wants to participate in the study (during acute phase) - Signed Informed Consent Form (after acute phase) Exclusion Criteria: - Pregnant or nursing woman - Woman of child bearing potential and not taking adequate contraceptive precautions - 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
A location was updated in Gothenburg.
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The overall status was updated to "Recruiting" at Sahlgrenska University Hospital, Stroke Unit.
19 Apr '16
A location was updated in Gothenburg.
New
The overall status was removed for Ambulans och Prehospital Akutsjukvård.
A location was updated in Gothenburg.
New
The overall status was updated to "Recruiting" at Sahlgrenska University Hospital, Stroke Unit.