Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
To evaluate the XACT ACE Robotic System in lung procedures.
详细描述
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous lung procedures. The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years of age
- •Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc.
- •Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
- •Subject is willing to sign informed consent
- •Subject is capable of adhering to study procedures
排除标准
- •Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
- •Subject with significant coagulopathy
- •Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
- •Subjects who are pregnant or nursing
- •Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)
研究组 & 干预措施
Study arm
Subjects undergoing procedures with the XACT ACE Robotic system.
干预措施: XACT ACE Robotics study arm (Device)
结局指标
主要结局
Adverse Events
时间窗: 30 days
Incidence, severity, and frequency of adverse events and device-related adverse events
次要结局
- Secondary Performance Evaluation - Clinical Accuracy(1 hour)
- Secondary Performance Evaluation - System Accuracy(1 hour)