A Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to Evaluate the SENSE Device's Ability to Detect Intracranial Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Primary Outcome
研究概览
简要总结
This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH or traumatic intracranial bleeding for the detection and monitoring of intracranial hemorrhages.
详细描述
This study is a two-stage, pivotal, prospective, nonrandomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scans. All subjects who meet eligibility criteria should be enrolled. An algorithm has been developed for detecting ICH, which will now be tested in this independent cohort of subjects. CT scans will be grouped into: 1) ICH, or 2) non- ICH. Enrollment will continue until 120 subjects with and 120 without ICH have been enrolled. An interim analysis will occur after ~60 subjects each with and without ICH have been enrolled and the sample size may be increased at the direction of the DMC as warranted. In Stage 1, 150 subjects (with primary spontaneous ICH or traumatic intracranial hemorrhage) were enrolled for the development of a hemorrhage detection algorithm. In Stage 2, the algorithm developed in Stage 1 will be tested in an independent cohort of up to 300 subjects. All subjects who meet eligibility criteria should be enrolled. The gold standard will be the CT results. The algorithm established in Stage 1 will be tested in this independent cohort of subjects. CT scans will be grouped into: 1) ICH or, 2) non-ICH. Enrollment will continue until ~60 subjects each with and without ICH have been enrolled. An interim analysis will occur after ~60 subjects each with and without ICH have been enrolled and the sample size may be increased at the direction of the DMC as warranted. All subjects' CT images will be reviewed by an independent neuroradiology core for classification as ICH or non-ICH, and ICH volume estimation. The treating clinicians and independent neuroradiologist will be blinded to the SENSE device findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients age 22 years and older
- •CT obtained in the mobile stroke unit, emergency department (ED) or hospital
排除标准
- •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,
- •Open skull fracture (closed skull fracture is not an exclusion),
- •Placement of an intraventricular catheter prior to 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
Primary Outcome
时间窗: 24-hours
Detection of ICH is the primary endpoint for this study. To establish the sensitivity (primary) and specificity (key secondary) for ICH detection. The results from the CT (ICH versus no ICH) scan will serve as the gold standard.
次要结局
未报告次要终点