Safety and Efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) System in Detection of Colorectal Neoplasia's During Real-time Colonoscopy: A European Prospective, Multicenter, Randomized Controlled Trial (EuroCADe)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 850
- 试验地点
- 6
- 主要终点
- Adenoma Detection Rate (ADR)
研究概览
简要总结
This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.
详细描述
This Study aims to provide insight into whether the application of Artificial Intelligence (Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •45-80 years
- •Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance
排除标准
- •Lack of informed written consent
- •History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
- •Prior failed colonoscopy
- •multiple historic prior failed colonoscopy due to poor bowel preparation OR
- •a single prior failed colonoscopy due to reasons other than poor bowel preparation
- •Biopsy/anesthesia/sedation contraindications
- •History of radio- and/or chemotherapy
- •Concurrent participation in another competing clinical study
结局指标
主要结局
Adenoma Detection Rate (ADR)
时间窗: During procedure
Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm).
Positive Predictive Value (PPV)
时间窗: During procedure
Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (\>10mm) hyperplastic polyps divided by the total number of resections.
次要结局
- Adenoma Per Colonoscopy (APC)(During procedure)
- Total Procedure Time(During procedure)
- Endoscope withdrawal time(During procedure)