Evaluate the Efficacy and Safety of an Artificial Intelligence-Based Endoscopic Image Analysis Software During Real-Time Upper Gastrointestinal Endoscopic Examinations: A Prospective, Single-Center, Post-Market Exploratory Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 19(Year) 至 No Limit（—）
- 性别
- All
入选标准
- •Subjects who voluntarily agreed to participate and signed the written informed consent form
- •Adults aged 19 years or older scheduled to undergo endoscopy
排除标准
- •Patients undergoing emergency endoscopy
- •Cases in which gastric visualization is not possible due to foreign bodies or patient hypersensitivity
- •Patients with anatomical alterations of the stomach
研究组 & 干预措施
Medical Device : The investigational device (MD-GA-300) is an endoscopic image analysis software that displays abnormal areas (such as elevated or depressed lesions) on endoscopic images in real time. The expert group will perform upper gastrointestinal endoscopy without using AI, capturing images of lesions observed during the examination and recording the number of lesions immediately after the procedure. The novice group without AI application will perform upper gastrointestinal endoscopy in the same manner, without using AI. The novice group with AI application will perform upper gastrointestinal endoscopy with the AI function activated, in which the software displays abnormal areas in real time, and the examination will be conducted with reference to these AI-generated indications.
干预措施: Medical Device : The investigational device (MD-GA-300) is an endoscopic image analysis software that displays abnormal areas (such as elevated or depressed lesions) on endoscopic images in real time. The expert group will perform upper gastrointestinal endoscopy without using AI, capturing images of lesions observed during the examination and recording the number of lesions immediately after the procedure. The novice group without AI application will perform upper gastrointestinal endoscopy in the same manner, without using AI. The novice group with AI application will perform upper gastrointestinal endoscopy with the AI function activated, in which the software displays abnormal areas in real time, and the examination will be conducted with reference to these AI-generated indications.