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.
Aged 18 years or older.
Willing to participate voluntarily in the clinical trial and provide written informed consent.
Capable of communicating with researchers and complying with trial requirements.
Pregnant individuals.
Individuals at high risk of gastrointestinal obstruction, including those identified as being at risk of gastrointestinal stenosis based on the Gastrointestinal Stenosis Assessment Form, those in whom gastrointestinal obstruction cannot be clinically excluded, or individuals with a history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy.
Individuals with swallowing dysfunction.
Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
Nanfang Hospital, Southern Medical University
Lead sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
ZhuHai Hospital
Collaborator
Pingshan People's Hospital
Collaborator
Ganzhou City People's Hospital
Collaborator
Wuxi People's Hospital
Collaborator
Prince of Wales Hospital, Shatin, Hong Kong
Collaborator
Longgang District People's Hospital of Shenzhen
Collaborator
Mianyang Central Hospital
Collaborator
Renhua People's Hospital
Collaborator