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临床试验/NCT04222439
NCT04222439Unknown不适用

Development and Validation of a Deep Learning Algorithm for the Diagnosis of Gastrointestinal Diseases

Shandong University1 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100,000
试验地点
1
主要终点
The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.

研究概览

简要总结

The purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

详细描述

Recently, deep learning algorithm based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. However, there is still a blank in recognition of all gastrointestinal diseases. This study aim to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals.

排除标准

  • 未提供

研究组 & 干预措施

AI monitoring gastrointestinal endoscopy

Experimental

After receiving standard preparation regimen, patients go through colonoscopy or gastroscopy under the AI monitoring device. The whole procedure is monitored by AI associated recognition system. Gastrointestinal diseases will be detect and diagnosis in which the AI device will automatically captured relevant images and report the site of each segment on the screen. Histology analysis is set as a golden standard. Then all the AI captured images will be reviewed by human group, which consists of three to five experienced endoscopic physicians.

干预措施: AI for the Diagnosis of Gastrointestinal Diseases (Device)

结局指标

主要结局

The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.

时间窗: 1 month

The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.

次要结局

  • The diagnostic sensitivity of gastrointestinal diseases with deep learning algorithm.(1 month)
  • The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.(1 month)
  • The diagnostic positive predictive value of gastrointestinal diseases with deep learning algorithm.(1 month)
  • The diagnostic negative predictive value of gastrointestinal diseases with deep learning algorithm.(1month)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiuli Zuo

director of Qilu Hospital gastroenterology department

Shandong University

研究点 (1)

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