Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Radiation Dose during Procedure
研究概览
简要总结
This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.
详细描述
This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking is impossible due to the hardware that is present when using the SCENERGY
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy.
排除标准
- •any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.
结局指标
主要结局
Radiation Dose during Procedure
时间窗: 1 hour
The number of CTs or Fluoroscopy shots during the biopsy
次要结局
- Time to Reach Target of Biopsy(1 hour)
- Experience Level(1 hour)
