Efficacy of an Artificial Intelligence System for Lesion Detection and Characterization (CADe and CADx) During Colorectal Cancer Screening Colonoscopies: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.
研究概览
简要总结
The goal of this clinical trial is to determine whether using artificial intelligence (AI) can improve the detection and characterization of abnormal growths (polyps) during colonoscopy in adults aged 50 to 74 years who are undergoing colorectal cancer screening after a positive stool test.
The main questions it aims to answer are:
- Does AI assistance increase the detection of adenomas or advanced colorectal neoplasia?
- Does AI provide more accurate optical diagnosis of polyps compared to standard assessment by endoscopists?
Researchers will compare colonoscopies performed with AI assistance (using the CAD EYE™ system) to standard colonoscopies without AI to see if AI improves detection rates or diagnostic accuracy.
Participants will:
- Undergo a screening colonoscopy after a positive fecal immunochemical test (FIT)
- Be randomly assigned to either an AI-assisted or standard colonoscopy group
- Have any detected polyps removed and analyzed
- Receive either AI-based or physician-based optical diagnosis of polyps during the procedure
This study helps evaluate whether AI can make colonoscopies more effective and reduce unnecessary polyp removals.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 50 to 74 years
- •Positive fecal immunochemical test (FIT) result (≥100 ng/mL)
- •Scheduled for screening colonoscopy within a population-based colorectal cancer screening program
- •Able and willing to provide written informed consent
排除标准
- •Incomplete colonoscopy (e.g., failure to reach the cecum)
- •Inadequate bowel preparation
- •History of colorectal surgery
- •Inability to provide informed consent
结局指标
主要结局
To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.
时间窗: During the screening colonoscopy visit (single time point assessment on the day of the procedure).
次要结局
- To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy.(During the screening colonoscopy visit (single time point assessment on the day of the procedure).)
研究者
Javier Santos Fernández
Clinical Trials Coordinator
University Care Complex of Palencia