A Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study toEvaluate the SENSE Device’s Ability to Detect Intracranial Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
- 试验地点
- 6
- 主要终点
- Detection of ICH is the primary endpoint for this study. To establish the sensitivity (primary) and specificity (key
研究概览
简要总结
This study is a pivotal, prospective, non-randomized, multi-center, comparison of the SENSE device and CT scans. All subjects who meet eligibility criteria should be enrolled. The algorithm for ICH detection described above will be tested in an independent cohort of ~120 subjects each with and without ICH have been enrolled. The gold standard will be based on the CT results. CT scans will be grouped into: 1) ICH or, 2) non-ICH.
ICH is defined as a diagnosis of primary spontaneous ICH (parenchymal intracerebral hemorrhage, subarachnoid hemorrhage, spontaneous subdural hematoma) or traumatic intracranial bleeding (defined as subarachnoid hemorrhage, epidural hemorrhage, subdural hemorrhage and/or traumatic contusions/intraparenchymal hemorrhage).
All images will be reviewed by an independent neuroradiology core lab for classification as ICH or non-ICH, and for ICH volume estimation. The treating clinicians and independent neuroradiology core lab will be blinded to the SENSE device findings. For subjects who have multiple CT scans, the CT scan closest in time (while still preceding) SENSE device placement will be used for adjudication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 22.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who meet all of the following inclusion criteria will be considered candidates for study enrollment:
- •Male or female patients age 22 years and older
- •CT obtained in the mobile stroke unit, emergency department (ED) or hospital Informed consent provided by study subject or, if subject is unable, by subject’s next of kin or legal guardian.
排除标准
- •All subjects meeting any of the following criteria will be excluded from this study:
- •Female patients who are pregnant or lactating
- •SENSE device cannot be applied within 6 hours of a standard of care CT,
- •Metallic intracranial clip, coil, device (such as ICP monitor),or penetrating metallic shrapnel,
- •Metallic EEG leads in place at the time of planned enrollment,
- •Hemorrhagic transformation of ischemic stroke,) as etiology of ICH,
- •Treatment with intravenous thrombolysis or embolectomy prior to enrollment,
- •Clinical uncertainty about whether intracranial hemorrhage is present on the pre-enrollment head CT, and
- •Presence or history of any other condition or finding that, in the investigator’s opinion, makes the patient unsuitable as a candidate for SENSE device monitoring or study participation or may confound the outcome of the study.
结局指标
主要结局
Detection of ICH is the primary endpoint for this study. To establish the sensitivity (primary) and specificity (key
时间窗: Time Frame: 48 hours
secondary) for ICH detection. The results from the CT (ICH
时间窗: Time Frame: 48 hours
versus no ICH) scan will serve as the gold standard
时间窗: Time Frame: 48 hours
次要结局
- To estimate the specificity of the SENSE device for classifying patients undergoing head CT as non-ICH versus ICH.(The study duration is a total of up to 24 hours which includes at least 5 minutes of)
- To estimate the positive predictive value (PPV) of the SENSE device for classifying(patients undergoing head CT as ICH versus non-ICH.)
- To estimate the negative predictive value (NPV) of the SENSE device for classifying(patients undergoing head CT as ICH versus non-ICH.)
- To estimate the PPV, NPV, specificity & sensitivity of the SENSE device for correctly(classifying patients with intracranial hemorrhage after excluding patients whose total)