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Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
Sponsor: Nanfang Hospital, Southern Medical University
Summary
The goal of this clinical trial is to evaluate the diagnostic accuracy of the AI-integrated Capsule Gastroscopy (ACG) system in simulated home-use conditions for detecting upper gastrointestinal (UGI) abnormalities. It will also compare the diagnostic accuracy and time efficiency of AI-assisted interpretation versus manual reading of ACG data. The main questions it aims to answer are: What is the diagnostic accuracy of the ACG system, using conventional esophagogastroduodenoscopy (EGD) as a standard of reference? Does AI-assisted ACG reading improve diagnostic accuracy or reduce reading time compared to manual ACG video reading? Researchers will compare ACG results to conventional EGD findings (standard of reference) to determine if ACG can serve as a reliable method for UGI disease detection in home scenarios. Participants will: Undergo an ACG examination in a simulated home environment. Complete an EGD procedure within 24 hours post-ACG ingestion.
Official title: A Multicenter, Prospective Study of Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
482
Start Date
2025-03-03
Completion Date
2026-12-31
Last Updated
2025-07-09
Healthy Volunteers
Yes
Conditions
Interventions
AI-integrated Capsule Gastroscopy (ACG) examination
Product name: Gastric Capsule Endoscope System Specification model: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.
Electronic gastroduodenoscopy (EGD) examination
EGD was the reference standard against which ACG was compared, and it was performed within 24 hours post-ACG ingestion time. Product name: Electronic gastrointestinal endoscope (EGD) Specifications and models: GIF-290 series Manufacturer: Olympus, Tokyo, Japan
Locations (12)
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Renhua People's Hospital
Shaoguan, Guangdong, China
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Pingshan People's Hospital
Shenzhen, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
Wuxi People's Hospital.
Wuxi, Jiangsu, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Prince of Wales Hospital of Hong Kong
Hong Kong, Hong Kong
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy