跳至主要内容
临床试验/NCT04358198
NCT04358198Unknown不适用

Usefulness of Artificial Intelligence (AI) for Gastric Intestinal Metaplasia Diagnosis

King Chulalongkorn Memorial Hospital2 个研究点 分布在 1 个国家目标入组 120 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
入组人数
120
试验地点
2
主要终点
Accuracy of AI for GIM diagnosis

研究概览

简要总结

This study will use artificial intelligence (AI) for diagnosing gastric intestinal metaplasia.

详细描述

The patients with previously diagnose gastric intestinal metaplasia (GIM) and have the surveillance gastroscopy will be enrolled. The routine surveillance program will be performed additional to taking photo at both GIM and normal mucosa at least 5 pictures in each. Biopsy will be done to confirm the diagnosis of GIM and normal mucosa. All pictures will be inserted to AI algorithm based on the convolutional neural network (CNN). Then, the AI program will be validated in daily endoscopy compared with pathology. Accuracy, sensitivity and specificity can be calculated by 2x2 table.

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

  • More than 18 years of age
  • Able to sign a consent form

排除标准

  • History of gastric surgery
  • Coagulopathy
  • Pregnancy/Breast feeding

结局指标

主要结局

Accuracy of AI for GIM diagnosis

时间窗: 1 year

Accuracy, sensitivity, specificity can be calculated by 2x2 table (pathology is a gold standard)

次要结局

未报告次要终点

研究者

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

Rapat Pittayanon

Principle investigator

King Chulalongkorn Memorial Hospital

研究点 (2)

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