Real Life AI in Polyp Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Mean withdrawal time comparison
研究概览
简要总结
The objective of this study is to compare the polyp detection rate (PDR) of endoscopists unaware of a commercially available artificial intelligence (AI) device for polyp detection during colonoscopy and the PDR of endoscopists with the aid of such a device. Moreover, an extensive characterization of the performance of this device will be done.
详细描述
Recently, there have been remarkable breakthroughs in the introduction of deep learning techniques, especially convolutional neural networks (CNNs), in assisting clinical diagnosis in different medical fields. One of these artificial intelligence (AI) devices to diagnose colon polyps during colonoscopy was launched in October 2019. Its intended use is to work as an adjunct to the endoscopist during a colonoscopy with the purpose of highlighting regions with visual characteristics consistent with different types of mucosal abnormalities.
It is essential to know whether deep learning algorithms can really help endoscopists during colonoscopies. Several studies have already addressed this issue with different approaches and results. However, one common drawback of these type of Machine vs Human retrospective studies is endoscopist bias. It is usually generated because of human natural competitive spirit against machine or human relaxation because of AI-reliance. This can have an effect in the overall results.
The investigators perfomed colonoscopies with the use of a commercially available AI system to detect colonic polyps and recorded them during clinical routine. Additionally from March 2019 - May 2019, 120 colonoscopy videos were performed and captured prospectively without the use of AI.
In this study, the investigators plan to retrospectively compare those two video sets regarding the polyp detection rate, withdrawal time and polyp identification characteristics of the AI system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonoscopies for Polyp detection
排除标准
- •Colonoscopies for Inflammatory Bowel Disease (IBD).
- •Colonoscopies for work up of an active bleeding
结局指标
主要结局
Mean withdrawal time comparison
时间窗: 45 minutes
Mean withdrawal time comparison
Polyp detection rate comparison
时间窗: 45 minutes
Number of polyps detected divided by number of colonoscopies
次要结局
- Reaction Time Analysis(45 minutes)
- AI-Polyp bounding boxes - True Positive Evaluation(45 minutes)
- AI-Polyp bounding boxes - False Positive Quantitative Evaluation(45 minutes)
- AI-Polyp bounding boxes - False Negative Evaluation(45 minutes)
研究者
Alexander Hann
Principal Investigator
Wuerzburg University Hospital
