跳至主要内容
临床试验/NCT04260321
NCT04260321已完成不适用

The AID Study 2: Artificial Intelligence for Colorectal Adenoma Detection 2

Istituto Clinico Humanitas5 个研究点 分布在 2 个国家目标入组 700 人开始时间: 2020年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
试验地点
5
主要终点
Non-inferiority of AI-aided colonoscopy in terms of ADR

研究概览

简要总结

Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. "Back-to-back" colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6% for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12%. The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC.

Limitations in human visual perception and other human biases such as fatigue, distraction, level of alertness during examination increases such recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC. In the past years, a number of CAD systems for detection of polyps from endoscopy images have been described. However, the benefits of traditional CAD technologies in colonoscopy appear to be contradictory, therefore they should be improved to be ultimately considered useful. Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have shown potential to assist polyp detection during colonoscopy.

Average experienced endoscopists (each having performed <2000 screening colonoscopies) will perform the endoscopic procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All 40-80 years-old subjects undergoing a colonoscopy

排除标准

  • subjects with personal history of CRC, or IBD.
  • patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale > 2 in any colonic segment).
  • patients with previous colonic resection.
  • patients on antithrombotic therapy, precluding polyp resection.
  • patients who were not able or refused to give informed written consent.

结局指标

主要结局

Non-inferiority of AI-aided colonoscopy in terms of ADR

时间窗: 5 Months

The proportion of participants with at least one adenoma (per-patient analysis).

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验

The AID Study 2: Artificial Intelligence for... | 临床试验