Feasibility of the Utilization of Siemens Prototypes in Minimally Invasive ICH Evacuation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Volume of Post-procedure hemorrhage
研究概览
简要总结
The aim of the project is to collect pre-procedural CT scans, intra-procedural post-evacuation scans as well as immediate post-procedural CT scans to evaluate and collect feedback of two Siemens prototypes: 1) perfusion prototype and 2) automatic hemorrhage detection prototype. The assessment of the prototypes, including its features will focus on the feasibility, usefulness as well as the potential clinical value add in minimally invasive ICH treatment.
详细描述
The aim of the project is to prospectively collect pre-procedural CT scans, intraprocedural scans post-evacuation (7s DynaCT Sine Spin and DynaCT Multiphase) and immediate post-procedural CT scans to evaluate and collect feedback of two Siemens prototypes. The assessment of the prototypes, including its features, will focus on the feasibility, usefulness, and potential clinical value. In addition to the prospective data collection outlined above, already available pre- and post procedural CT data sets as well as pre- and post-evacuation DynaCT Sine Spin data sets will be collected retrospectively (n=5). These data sets were acquired as part of standard of care procedures. The additional data sets will also be included in the evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 ≥ 18 years old
- •Patient is planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
排除标准
- •Patient is < 18 years old
- •Patient is not planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
研究组 & 干预措施
DynaCT Multiphase scan
All enrolled patients will undergo an extra DynaCT Multiphase scan.
干预措施: DynaCT Multiphase (Device)
DynaCT Multiphase scan
All enrolled patients will undergo an extra DynaCT Multiphase scan.
干预措施: DynaCT Sine Spin (Device)
结局指标
主要结局
Volume of Post-procedure hemorrhage
时间窗: Immediately post-procedure
Quantitative assessment of the comparison of the detected residual hemorrhage on the DynaCT Sine Spin data and the detected residual hematoma on the immediate post-procedural CT
次要结局
- Quantitative correlation outcomes of post-procedure hemorrhage(Immediately post-procedure)
- Qualitative assessment of the contours of post-procedure hemorrhage(Immediately post-procedure)
- Volume of Pre-procedure hemorrhage(Pre-procedure)
研究者
Christopher P Kellner
Associate Professor
Icahn School of Medicine at Mount Sinai