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临床试验/NCT04039529
NCT04039529撤回不适用

Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy

Clear Guide Medical2 个研究点 分布在 1 个国家开始时间: 2019年12月31日最近更新:
适应症

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

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)

研究者

发起方
Clear Guide Medical
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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