NCT05851716招募中不适用
A Prospective, Single-arm, Single-center Observational Study to Evaluate the Clinical Effectiveness of an Intelligent Reporting System for the Upper Gastrointestinal Endoscopy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Completeness of reporting lesions
研究概览
简要总结
The goal of this observational study is to evaluate the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The main question it aims to answer is: Whether the AI-based reporting system can improve the completeness of the reports, which are drafted by endoscopists with the AI assistance. Participants will undergo upper gastrointestinal endoscopy examination as routine. The junior endoscopists will draft the report with the assiatance of the AI system. And the senior and expert endoscopists will draft the report using the traditional reporting system without AI assistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Aged 18 years
- •Aim to undergo screening, surveillance, and diagnosis
- •Undergo sedated EGD
- •Able to read, understand, and sign informed consent
排除标准
- •EGD contraindications
- •Not suitable for sedated endoscopy after anaesthesia evaluation
- •Biopsy contraindications
- •Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
- •Upper gastrointestinal surgery or residual stomach
- •Not suitable for recruitment after investigator evaluation because of other high-risk conditions
结局指标
主要结局
Completeness of reporting lesions
时间窗: one month
Calculation method = number of report lesions / total number of lesions x 100%
次要结局
- Reporting time(one month)
- Completeness of report drafting on lesion features(one month)
- Accuracy of report drafting on lesion features(one month)
- Completeness of reporting lesions of AI system(one month)
- Accuracy of report drafting on lesion features of AI system(one month)
研究者
研究点 (1)
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