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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion criteria
1. Aged 18 years or older.
2. Individuals meeting the following criteria:
i. Healthy volunteers; ii. Suspected presence of gastrointestinal diseases, with one or more of the following clinical symptoms: abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion; iii. Follow-up of gastric lesions post-endoscopic resection.
3. Willing to participate voluntarily in the clinical trial and provide written informed consent.
4. Capable of communicating with researchers and complying with trial requirements.
Exclusion criteria
1. Pregnant individuals.
2. 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.
3. Individuals with swallowing dysfunction.
4. Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
5. Participants who are unable to comprehend and/or comply with physician instructions during the examination.
6. Individuals with other medical risks that contraindicate the use of a capsule gastric endoscopy system, or those deemed unsuitable for participation in this study at the discretion of the investigator.
Primary outcome measure(s)
Diagnostic accuracy of ACG in screening for common UGI abnormalities — Through study completion, an average of 1 year. 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.
Trial sites (12)
Facility
City
Region
Status
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou
Guangdong
Recruiting
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
Guangdong
Recruiting
Renhua People's Hospital
Shaoguan
Guangdong
Recruiting
Longgang District People's Hospital of Shenzhen
Shenzhen
Guangdong
Recruiting
Pingshan People's Hospital
Shenzhen
Guangdong
Recruiting
Zhuhai People's Hospital
Zhuhai
Guangdong
Recruiting
Wuxi People's Hospital.
Wuxi
Jiangsu
Recruiting
Ganzhou People's Hospital
Ganzhou
Jiangxi
Recruiting
Mianyang Central Hospital
Mianyang
Sichuan
Recruiting
Prince of Wales Hospital of Hong Kong
Hong Kong
Hong Kong
Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Italy
Not Yet Recruiting
More Nanfang Hospital, Southern Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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