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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Patient/healthy volunteer should be ≥ 18 years of age.
- •The patient/healthy volunteer has signed a written informed consent.
排除标准
- •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.
结局指标
主要结局
Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm.
时间窗: 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.
次要结局
- 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.)
- Correlation between subdural hematoma volumes estimated by CT and by mathematical analysis of 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 diagnostic procedure has an estimated duration of 30 minutes.)
研究者
Dr Thomas Skoglund
Principal Investigator
Sahlgrenska University Hospital