Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,472
- 试验地点
- 10
- 主要终点
- Adenomas per colonoscopy
研究概览
简要总结
The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adenomas per colonoscopy
时间窗: At the end of the procedure, 1 day
The total number of adenomas detected divided by the total number of colonoscopies.
Positive predictive value
时间窗: At the end of the procedure, 1 day
The total number of adenomas and serrated lesions detected divided by the total number of extractions.
次要结局
- Adenoma detection rate(At the end of the procedure, 1 day)
- Colorectal cancer surveillance interval(At the end of the procedure, 1 day)
- Sessile serrated lesions detected(At the end of the procedure, 1 day)