Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 137
- 试验地点
- 8
- 主要终点
- Adenoma Per Extraction (APE).
研究概览
简要总结
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).
Ultivision AI CADe is indicated for white light colonoscopy only.
详细描述
Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).
The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.
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
- Single (Outcomes Assessor)
盲法说明
Pathologist is blind to group assignment
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45 to 75 years;
- •Screening or surveillance colonoscopy.
- •Iinformed consent
排除标准
- •Colorectal cancer;
- •Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;
- •Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;
- •Positive Fecal Immunochemical Test;
- •Use anti-platelet agents or anticoagulants that prevent polyps removal;
- •Colon resection, not including the appendix;
- •Subject is pregnant or lactating.
结局指标
主要结局
Adenoma Per Extraction (APE).
时间窗: During the procedure/surgery
Non inferiority of Ultivision-AI arm versus control arm. Where APE is the fraction of adenoma, sessile serrated lesions, and large (\>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.
Adenoma per Colonoscopy (APC)
时间窗: During the procedure/surgery
Superiority of Ultivision-AI arm versus control arm. APC is defined as the total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
次要结局
未报告次要终点