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.
Crossover
AI-integrated Capsule Gastroscopy (ACG) examination
DeviceProduct name: Gastric Capsule Endoscope System Specification model: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.
Electronic gastroduodenoscopy (EGD) examination
DeviceEGD 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
Diagnostic accuracy of ACG in screening for common UGI abnormalities
EGD will serve as the reference standard. Metrics such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, diagnostic agreement rate, positive agreement rate (PAR), negative agreement rate (NAR), and diagnostic agreement rate of each individual lesion will be calculated. A participant will be classified as positive if any lesions are detected, including but not limited to: chronic atrophic gastritis, gastric ulcer, gastric polyps, gastric dysplasia, gastric masses, gastric cancer, gastric hemorrhage and other gastric lesions. Esophageal abnormalities (reflux esophagitis, Barrett's esophagus, esophageal cancer, esophageal masses and other abnormalities), duodenal abnormalities (duodenal ulcer, duodenal polyps, hemorrhage and other abnormalities). If no lesions are detected, or only chronic superficial gastritis is observed, the participant will be classified as negative.
Diagnostic accuracy and average diagnostic time between AI-assisted reading and manual reading of ACG
First, we will calculate metrics including accuracy, sensitivity, specificity, diagnostic agreement rate, PAR, NAR, PPV, NPV, and per-lesion agreement rate between EGD and AI-assisted ACG reading. Collected data will encompass lesion location, morphology, count, type, and estimated size. The diagnostic performance of AI-assisted reading will be compared with manual reading. Additionally, the average diagnostic time, number of images required for reading for both methods will be analyzed and compared. The capsule reading interface displays the current time. To calculate the diagnostic time, the reader will capture and save an image at both the start and end of each reading session.The average diagnostic time is calculated as follows: Average Diagnostic Time= Total diagnostic time/ Total number of diagnoses
Coverage rate of gastric anatomical sites of ACG
The coverage rates of gastric anatomical regions (including the fundus, antrum, cardia, body, sinus, and pylorus) detected by ACG and EGD will be analyzed. Coverage for each anatomical site and overall coverage will be calculated as follows: Coverage rate=Number of Covered Anatomical Sites / Total Number of umber of Anatomical Sites
Inspection completion rate of ACG
To assess the proportion of cases that complete ACG examination as required. The inspection completion rate will be calculated as follows: Inspection Completion Rate= Number of Completed Inspections / Total Number of Inspections X 100%
Average duration of ACG
The time from the capsule ingestion to expulsion of the capsule during the ACG examination will be recorded for each case, and the average duration will be calculated upon completion of all cases.
Safety evaluation
The primary safety indicators include the incidence and severity of adverse events. Secondary safety indicators encompass the device failure rate, which includes the inability to start the machine, abnormal shutdowns during the examination, interruptions during the examination due to device issues, lack of image acquisition post-examination, and other stability-related problems.
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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
