Detecting Chronic Subdural Hematoma With Microwave Technology
|ClinicalTrials.gov Identifier: NCT02282228|
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Subdural Hematoma Healthy Volunteers||Device: Medfield Strokefinder MD100||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
- Device: Medfield Strokefinder MD100
Measurement with Medfield Strokefinder MD100.
- Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm. [ 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.
- Correlation between subdural hematoma volumes estimated by CT and by mathematical analysis of microwave data. [ 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.
- Classification accuracy for estimating the position of the subdural hematoma through 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.
- Mean (± standard deviation) signal amplitude and phase shift caused by presence of chronic subdural hematoma. [ Time Frame: The diagnostic procedure has an estimated duration of 30 minutes. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282228
|Sahlgrenska University Hospital, Department of Neurosurgery|
|Gothenburg, Västra Götaland, Sweden, 413 45|
|Principal Investigator:||Thomas Skoglund, MD, PhD||Sahlgrenska University Hospital, Department of Neurosurgery|