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| Name | Class |
|---|---|
| Medfield Diagnostics | INDUSTRY |
| Chalmers University of Technology | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medfield Strokefinder MD100 | Device | Measurement with Medfield Strokefinder MD100. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Skoglund, MD, PhD | Sahlgrenska University Hospital, Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital, Department of Neurosurgery | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28287909 | Result | Ljungqvist J, Candefjord S, Persson M, Jonsson L, Skoglund T, Elam M. Clinical Evaluation of a Microwave-Based Device for Detection of Traumatic Intracranial Hemorrhage. J Neurotrauma. 2017 Jul 1;34(13):2176-2182. doi: 10.1089/neu.2016.4869. Epub 2017 Mar 13. |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| 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. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |