Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations
研究概览
简要总结
This is an observational study comparing a novel ultrasound-based imaging system (MAUI K3900) to standard-of-care (SoC) imaging systems used to guide and/or manage interventional radiologic procedures such as solid organ biopsies or lesion ablations.
详细描述
The purpose of this study is to obtain images using the MAUI Imaging Inc.'s K3900 Ultrasound System and compare them to images captured with FDA cleared imaging devices including traditional ultrasound, CT, MRI and Xray, and to study device safety. The information obtained in this study will inform MAUI Imaging as to what specific follow-on studies will be done in support of appropriate FDA clearances and/or claims. No diagnostic or patient management decisions will be made using the MAUI K3900 Ultrasound System in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing standard / routine interventional radiologic procedure
排除标准
- •Unwilling or unable to provide informed consent
结局指标
主要结局
Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations
时间窗: Up to 26 weeks
How does imaging with the K3900 compare with imaging currently used to guide solid organ biopsies or ablations, usually standard ultrasound, fluoroscopy, and/or CT?
次要结局
未报告次要终点