Ultrasound-CT Fusion System for Interventional Radiology Procedures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of CT scans or CT fluoroscopic images
研究概览
简要总结
The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the patient. This fusion system will be used to perform ultrasound guided needle placements for patients undergoing percutaneous CT guided needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is to prove that the new imaging fusion system is comparable to using either CT or US guidance alone to guide needle placement.
详细描述
A simple 20 patient study will be performed using the CG SCENERGY system. This fusion system will be used to perform image guided needle placements for patients undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis). Only patients who are already scheduled for a CT guided procedure will be screened. The study design is as follows:
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10 patients will have their procedure performed using the CGM SCENERGY US-CT fusion system and 10 patients will have their procedure performed using CT guidance only.
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Proper informed consent will be obtained
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Perform a CT scan with the optical adhesive skin markers in place. Markers are placed around the expected site of needle skin entry.
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The first 10 patients Group#1 (1-10) will be assigned to using the SCENERGY fusion system to complete the needle placement, and the next 10 patients Group #2 (11-20) will be assigned of continuing with CT guidance only to complete the needle placement.
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If in Group #1, the procedure will proceed as usual using the SCENERGY system to guide the needle to target. If in the Group #2, CT guidance will be used to place the needle to target.
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Once the needle is at the target, a confirmatory CT will be performed.
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If the target is reached (i.e., the software directed the interventional radiologist to the right place, e.g. for correctly biopsying a lesion), the trial is considered a "success" and the procedure continues as normal.
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If the needle is not in the right place, the trial is considered a "failure", and the procedure continues as normal without using the CGM software any further.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis)
- •Able to give written informed consent
排除标准
- •Unable to give informed consent
- •Patients undergoing CT guided needle-based interventions other than the procedures mentioned in the inclusion criteria
- •Prisoners, pregnant women, and children
研究组 & 干预措施
Ultrasound-CT Fusion Guidance
The participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement.
干预措施: Ultrasound-CT Fusion (Device)
CT Guidance
The participants in this group (control group) will receive the procedure with traditional CT methods and equipment, for guiding needle placement.
结局指标
主要结局
Number of CT scans or CT fluoroscopic images
时间窗: Immediately following intervention (within 2 hours)
次要结局
- Total procedure time(Immediately following intervention (within 2 hours))
- Time to target(Immediately following intervention (within 2 hours))
- Success of needle placement(Immediately following intervention (within 2 hours))