To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Obsevational Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,500
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control.
This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control.
This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 50 years old;
- •required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy;
- •voluntarily sign informed consent;
- •Commitment to abide by the study procedures and cooperate with the implementation of the whole process of the study.
排除标准
- •have participated in other clinical trials, signed informed consent and are in the follow-up period of other clinical trials;
- •known polyposis syndrome patients;
- •patients with known IBD;
- •patients considered by the investigators to be unsuitable or unable to undergo complete digestive endoscopy and related examinations;
- •high-risk diseases or other special conditions considered by the investigator to be unsuitable for clinical trial participation.
结局指标
主要结局
Adenoma detection rate
时间窗: During Endoscopy procesure
The numerator is the number of patients who had at least one adenoma on colonoscopy, and the denominator is the total number of patients who underwent colonoscopy
次要结局
- Detection rate of serrated adenoma(During Endoscopy procesure)
- Average number of polyps per colonoscopy(During Endoscopy procesure)
- Proportion of over-speed frames(During Endoscopy procesure)
- Polyp detection rate(During Endoscopy procesure)
- Colonoscopy time(During Endoscopy procesure)