NCT05006092已完成不适用
Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,149
- 试验地点
- 2
- 主要终点
- adenoma detection rate
研究概览
简要总结
Evaluation of an artificial intelligence system for polyp detection (CADe)
详细描述
We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •indication CRC surveillance endoscopy
- •indication post-polypectomy surveillance endoscopy
- •positive fecal immunochemical test in patients >=50 years
排除标准
- •reasonable suspicion of inflammatory bowl disease
- •reasonable suspicion of familiar polyposis Syndrome
- •Patient after radiation/resection of colonic parts
结局指标
主要结局
adenoma detection rate
时间窗: 4 months
proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas
次要结局
- withdrawal time(4 months)
- resection time(4 months)
- polyp detection rate(4 months)
- Boston Bowl Preparation Score(4 months)
研究者
研究点 (2)
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