Augmented Reality Real-Time Guidance With In-situ Feedback
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of completing the CT-guided needle placement procedure using the LUMENA guidance system
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and safety of using the LUMENA guidance system during clinical procedures in patients undergoing CT-guided needle Placement for kidney, liver, lymph node, abdominal mass and lung ablation/biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, ages 18-90 years
- •Patient referred to Interventional Radiology for CT-guided needle placement for ablation/biopsy.
排除标准
- •Patients who are unable to give informed consent themselves or through their parents.
- •Patients that do not fit into the gantry of the CT scanner.
- •Patients who are sensitive to radiation exposure such as pregnant women.
研究组 & 干预措施
LUMENA Augmented Reality Guidance
Participants will undergo clinically indicated CT-guided needle placement for ablation or biopsy with use of the LUMENA augmented reality guidance system.
干预措施: LUMENA Guidance System (Device)
结局指标
主要结局
Feasibility of completing the CT-guided needle placement procedure using the LUMENA guidance system
时间窗: 2 years
Feasibility will be assessed as the proportion of procedures successfully completed using the LUMENA guidance system without withdrawal of the system before completion. The procedure will be considered feasible if more than 80% of procedures are completed using the system.
Safety of CT-guided needle placement using the LUMENA guidance system as assessed by adverse events
时间窗: 2 years
Safety will be assessed by the occurrence of serious adverse events and total adverse events associated with the procedure. The safety endpoint is safe needle placement in the target without any serious adverse events and total adverse events less than 10%.
次要结局
- Accuracy of needle placement(1 day)
- Procedure time(1 day)
- Number of intermediary CT/fluoroscopy images(1 day)
- Operator usability assessment of the LUMENA guidance system(1 day)