Safety of the PET-511BTM Transesophageal Transducer (TEE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The TEE transducer passes safely into the esophagus.
研究概览
简要总结
The purpose of this study is to demonstrate the safety of the redesigned transesophageal echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through the mouth.
详细描述
The PET-511BTM is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.
The objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE 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
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients between the ages of 20 and 80
- •Informed consent understood and signed
- •Compliance with post-treatment follow-up protocol requirements
排除标准
- 未提供
结局指标
主要结局
The TEE transducer passes safely into the esophagus.
时间窗: during, 30 minutes, and 24 hours after the exam
次要结局
未报告次要终点