Observational Post-Market Study of the XACT ACE Robotic System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Proportion of successful procedures
研究概览
简要总结
Compile real world data on the use of the XACT ACE Robotic System
详细描述
The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures.
The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.
Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years of age
- •Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
- •Subject is willing to sign informed consent for the purposes of data collection
排除标准
- •No exclusion criteria other than listed in the product Instructions for Use (IFU)
结局指标
主要结局
Proportion of successful procedures
时间窗: 1 hour
To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation.
Assessment of Safety
时间窗: 2 hours post-procedure
Incidence of intra- and post-procedural events
System accuracy
时间窗: 1 hour
To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion.
次要结局
未报告次要终点