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临床试验/NCT04335318
NCT04335318已完成不适用

Real Life AI in Polyp Detection

Wuerzburg University Hospital2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2020年5月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Hann

Principal Investigator

Wuerzburg University Hospital

研究点 (2)

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