Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 主要终点
- Number of findings (abnormal GI findings, such as polyps and tec.) per diagnostic procedure, using Fuse® system
研究概览
简要总结
The intent of this study is to evaluate the performance and usability of Fuse in routine practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy) gastrointestinal endoscopy procedures. The study is open label, prospective and Post Marketing study.
详细描述
The intent of this study is to evaluate the performance and usability of Fuse in routine practice EndoChoice's Fuse system - Fuse is an FDA, CE and AMAR approved Endoscopic system (Gastroscope and Colonoscope).
Fuse® system The Fuse system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse system consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Fuse Colonoscopes in conjunction with the FuseBox™ processor are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects.
Fuse Gastroscopes in conjunction with the FuseBox™ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ages 18 at least
- •The subject has been scheduled for routine screening upper or lower endoscopy, diagnostic work up, or endoscopic surveillance.
- •Signed informed consent
排除标准
- •Subjects who are currently enrolled in another clinical study
结局指标
主要结局
Number of findings (abnormal GI findings, such as polyps and tec.) per diagnostic procedure, using Fuse® system
时间窗: 1 outpatient hospitalization day for subject
次要结局
未报告次要终点