Sahlgrenska University Hospital, Department of Neurosurgery
Gothenburg, Västra Götaland County, 413 45, Sweden
NCT Number: NCT02282228
An open study evaluating the sensitivity and specificity of a microwave-based device, Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Gothenburg, Västra Götaland County, 413 45, Sweden
This open study will enroll patients admitted for surgery of chronic subdural hematoma at the Department of Neurosurgery at Sahlgrenska University Hospital and compare them to measurements of healthy volunteers. Patients will be asked to participate in the study, as early as possible after admission. After physical examination, checking the inclusion/exclusion criteria, and after informed consent has been acquired, the microwave-based measurement will be performed. The diagnostic procedure is estimated to take 30 min whereof total subject measurement time will be less than five minutes. Healthy volunteers will be recruited in parallel and the same procedure as for the patients will be followed.
Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the microwave-based investigation is finalized.
To avoid measurement bias all measurements, for both patients and healthy volunteers, will be performed by the same operator.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measurement with Medfield Strokefinder MD100.
Time frame: The diagnostic procedure has an estimated duration of 30 minutes.
The diagnostic ability of the device is calculated using a leave-one-out cross-validation method.
Time frame: The diagnostic procedure has an estimated duration of 30 minutes.
Pearson's linear correlation coefficient is calculated by comparing subdural hematoma volumes estimated by analysis of CT image and by a mathematical analysis of the microwave data.
Time frame: The diagnostic procedure has an estimated duration of 30 minutes.
The ability of the device to estimate location of subdural hematoma is evaluated using a classification algorithm and leave-one-out cross validation.
Time frame: The diagnostic procedure has an estimated duration of 30 minutes.
Sahlgrenska University Hospital
Other
Detecting Chronic Subdural Hematoma With Microwave Technology - An Open Study Evaluating the Sensitivity and Specificity of a Microwave-based Device, Medfield Strokefinder MD100, to Detect Chronic Subdural Hematoma
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