An Open Multicentre Trial on Suspected Stroke Patients Evaluating the Possibility to Use Microwave Technology to Differentiate Hemorrhage From Infarction in the Acute Phase
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient group A vs. group B, using the leave-one-out cross validation (LOOCV) method
研究概览
简要总结
This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. Follow-up microwave measurements will be performed after the acute phase. The study assesses the diagnostic capability and safety of Strokefinder MD100.
详细描述
This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The investigator will assess and control the inclusion/exclusion criteria. If the patient is confirmed to be suitable for the trial, the patient is asked to give oral informed consent. If the answer is affirmative the microwave measurement will be performed. The procedure will take less than five minutes (the duration of the actual measurement procedure is 1.5 minutes) and will not interfere with the patient's standard of care during the hospital stay. Written informed consent is acquired by the investigator, as soon as possible after the acute phase of care is completed. Follow-up microwave measurements will be performed after the acute phase.
The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation (LOOCV) method with the CT diagnosis as ground truth.
Safety will be evaluated throughout the trial, and a safety follow-up will be performed by the investigator 24 hours after the last microwave measurement. No further follow-up of patients is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Patient should be ≥ 18 years of age
- •Patient has clinical signs of stroke
- •Patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase)
- •Signed Informed Consent Form (after acute phase)
排除标准
- •Pregnant or nursing woman
- •Fertile woman where pregnancy cannot be excluded
- •Patient diagnosed with a condition associated with risk of poor protocol compliance
- •The diagnostic procedure is deemed to interfere with the standard of care
- •Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment
- •Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrolment
结局指标
主要结局
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient group A vs. group B, using the leave-one-out cross validation (LOOCV) method
时间窗: The diagnostic procedure will take less than 5 minutes
次要结局
- Any adverse events occurring within 24 hours from the measurement procedure(s)(Within 24 hours)
- The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method(The diagnostic procedure will take less than 5 minutes)
研究者
Mikael Elam
Professor, MD
Sahlgrenska University Hospital, Sweden