Evaluation of the Safety, Effectiveness and Usability of the XACT Robotic System for Image Guided Percutaneous Lung Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- System accuracy will be determined by the measured distance from the tip of the needle/tool to the target.
研究概览
简要总结
This is a prospective, single arm study, to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite. eg. core, biopsy, will participate in the study. System and clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.
详细描述
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. The study will be approved by the Institutional Review Board (IRB) at each of the participating centers prior to patient enrollment.
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., and willing to sign an informed consent document will be screened for compliance with the study inclusion and exclusion criteria.
A total of thirty (41) subjects will be enrolled in the study at 5 medical centers. The intention is to recruit subjects, which will cover a variety of CT-guided interventional lung procedures and a variety of different procedural tools that may be used with the device. Investigators will screen patients based on the inclusion/exclusion criteria described below and the subjects' demographic, general medical history, medical condition/indication, coagulation factors, concomitant medications and vital signs will be obtained.
The system accuracy will be the primary efficacy endpoint and is defined as the measured distance from the tip of the needle/tool to the target, once the XACT robot reaches the pre-defined target .
Clinical accuracy will be the secondary efficacy endpoint and is defined as the ability to place the instrument or procedural tool at a location suitable for the planned intervention. The investigator will review the final instrument position on the post-placement CT images to determine if the pre-operative planned target was reached. This information will be used to calculate success rate.
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
- •Men and women over 18 years of age
- •Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc.
- •Subject is capable and willing to provide informed consent.
- •Subject is capable and willing to adhere to the study procedures.
排除标准
- •Subjects in whom the target is written 1 cm of a major blood vessel or major nerve.
- •Subject with lesion in the central and peripheral nervous system and the spine.
- •Subjects in whom the target is within 1 cm of a major blood vessel or major nerve.
- •Subject with significant coagulopathy
- •Subjects with a preexisting conditions, which, in the opinion of the investigator, may interfere with the conduct of the study.
- •Subjects with an unstable medical condition, e.g. unstable hypertension, unstable cardiac disease, etc.
- •Subjects who are uncooperative or cannot follow instructions.
- •Subjects with a mental state that may preclude completion of the study procedure.
- •Female subjects who are pregnant or nursing.
结局指标
主要结局
System accuracy will be determined by the measured distance from the tip of the needle/tool to the target.
时间窗: At the end of each interventional procedure, approximately 1 hour
The primary endpoint of the study is to evaluate the system accuracy of the XACT System. System accuracy of the study will be determined by the measured distance from the tip of the needle/tool to the target, once the XACT Robot reaches the pre-defined target.
次要结局
- Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure.(At the end of each interventional procedure, approximately 1 hour)