跳至主要内容
临床试验/NCT05479253
NCT05479253Unknown不适用

A Single-center Study of an AI-assisted Endoscopy Report System In Improving Reporting Quality

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Accuracy of lesion location

研究概览

简要总结

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for endoscopy report quality in endoscopists. The subjects would be divided into two groups. For the collected endoscopic videos, group A would complete the endoscopy report with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the upper gastrointestinal tract is divided into 26 parts). Group B would complete the endoscopy report without special prompts. After a period of forgetting, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the endoscopy report. Then, the completeness of the report lesion, the accuracy of the lesion location, the completeness of the lesion and the standard part in the captured images, and so on were compared with or without AI assistance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females who are over 18 years old;
  • After qualified medical education and obtained the Certificate of Chinese medical practitioner;

排除标准

  • Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;
  • The researcher believes that the subjects are not suitable for participating in clinical trials.

结局指标

主要结局

Accuracy of lesion location

时间窗: one month

Accuracy of lesion location with or without AI-assisted. Calculation method = number of lesion with correct location / total number of lesions x 100%

Integrity of standard part in captured images

时间窗: one month

Lesion integrity in captured images with or without AI-assisted. Calculation method = number of standard parts in captured images / the actual number of standard parts covered by the examination x 100%

Integrity of report lesion

时间窗: one month

Report lesion integrity with or without AI-assisted. Calculation method = number of report lesions / total number of lesions x 100%

Integrity of lesion in captured images

时间窗: one month

Lesion integrity in captured images with or without AI-assisted. Calculation method = number of lesions in captured images / total number of lesions x 100%

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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