Detecting Chronic Subdural Hematoma With Microwave Technology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Subdural Hematoma, Healthy Volunteers

Intervention / Treatment
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* Device: Medfield Strokefinder MD100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient admitted for surgery of chronic subdural hematoma. A CT scan of the patient has been performed, within the latest 96 hours. The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5. Patient/healthy volunteer should be ≥ 18 years of age. The patient/healthy volunteer has signed a written informed consent. Exclusion Criteria: Females who are pregnant or breast feeding women. Patient/healthy volunteer has a shunt or other foreign object implanted in the brain. Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medfield Strokefinder MD100|Measurement with Medfield Strokefinder MD100.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm. | The diagnostic ability of the device is calculated using a leave-one-out cross-validation method. | The diagnostic procedure has an estimated duration of 30 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between subdural hematoma volumes estimated by CT and by mathematical analysis of microwave data. | 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. | The diagnostic procedure has an estimated duration of 30 minutes. | 
| Classification accuracy for estimating the position of the subdural hematoma through a mathematical analysis of the microwave data. | The ability of the device to estimate location of subdural hematoma is evaluated using a classification algorithm and leave-one-out cross validation. | The diagnostic procedure has an estimated duration of 30 minutes. | 
| Mean (± standard deviation) signal amplitude and phase shift caused by presence of chronic subdural hematoma. |  | The diagnostic procedure has an estimated duration of 30 minutes. |