A Single-center, Prospective, Parallel Randomized Controlled Study Evaluating the Clinical Effectiveness of an Intelligent Graphic Report System for Upper Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Completeness of reporting lesions
研究概览
简要总结
The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
研究组 & 干预措施
Experimental group
Physicians draft EGD reports with the assistance of the AI-based reporting system.
干预措施: AI-based reporting system (Diagnostic Test)
Control group
Physicians use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.
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
- Accuracy of report drafting on lesion features(one month)
- Completeness of reporting lesions of AI system(one month)
- Physician satisfaction survey(one month)
- Completeness of report drafting on lesion features(one month)
- Reporting time(one month)
- Accuracy of report drafting on lesion features of AI system(one month)