Exploratory Study of Upper and Lower Endoscopic Fuse System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 主要终点
- Performance, usability and ease of use (performance questionnaire)
研究概览
简要总结
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
详细描述
The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients ages of 18-75
- •The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
- •Signed informed consent form
排除标准
- •Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
- •Patients who are unable to consent
- •Pregnant female patients of any age.
研究组 & 干预措施
Endoscopy exploratory single arm
干预措施: Fuse® Colonoscope (Device)
Endoscopy exploratory single arm
干预措施: Fuse® Gastroscope (Device)
结局指标
主要结局
Performance, usability and ease of use (performance questionnaire)
时间窗: Through study completion, estimate average of 1 year
The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer
次要结局
- Safety (adverse and severe adverse events)(Through study completion, estimate average of 1 year)