The endoscopic diagnosis of early gastric cancer.
Kenshi Yao
https://pubmed.ncbi.nlm.nih.gov/24714327Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06848400
A Multicenter, Prospective Study of Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-07-09
482
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
F
Fondazione Poliambulanza Istituto Ospedaliero
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic accuracy of an AI-integrated Capsule Gastroscopy (ACG) system called GICE-1000 for detecting upper gastrointestinal (UGI) abnormalities in simulated home-use conditions. This study compares the ACG system's results to conventional esophagogastroduodenoscopy (EGD), the current gold standard, to determine if the ACG can be a reliable and comfortable alternative for screening gastric diseases. It also assesses if AI-assisted reading of ACG videos improves diagnostic accuracy or reduces reading time compared to manual review. Participants will undergo the ACG examination in a simulated home environment after fasting and taking medications to clear gastric mucus. They follow video instructions to swallow the capsule and adjust body positions during the procedure. The capsule data is uploaded for analysis. Within 24 hours, participants also receive an EGD performed by experienced endoscopists blinded to ACG results. The ACG videos are reviewed both manually and with AI assistance to document findings and compare reading efficiency. During the study, participants provide informed consent, undergo fasting and preparation, and complete both ACG and EGD procedures. Researchers collect detailed imaging data, record abnormalities, and evaluate factors such as image quality and gastric cleanliness. The main outcome is the diagnostic accuracy of ACG for common UGI abnormalities. Secondary outcomes include comparison of diagnostic time between AI-assisted and manual readings and other measures related to examination completeness, image quality, and participant satisfaction. The total study duration includes screening, intervention, and follow-up periods, ending with data analysis and reporting.
CONDITIONS
Brief Title
Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Healthy volunteers or individuals with suspected gastrointestinal disease symptoms such as abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion
- Individuals undergoing follow-up after gastric lesion endoscopic resection
- Willing to participate voluntarily and provide written informed consent
- Able to communicate with researchers and comply with study requirements
You will not qualify if you...
- Pregnant individuals
- High risk of gastrointestinal obstruction or stenosis, or history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy
- Individuals with swallowing dysfunction
- Those unfit for or unwilling to undergo surgery
- Unable to understand or follow physician instructions during the examination
- Other medical risks contraindicating capsule gastroscopy or deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Preparation for Capsule Gastroscopy
Duration - 1 day
Participants prepare for the capsule gastroscopy by fasting for 8 hours and taking mucolytics and anti-foaming agents before the examination.
1 visit (in-person)
Capsule Gastroscopy Examination
Duration - Same day as preparation
Participants undergo the AI-integrated Capsule Gastroscopy (ACG) by swallowing a capsule and following video instructions to change body positions for examination. They remain blinded to the real-time video during the procedure.
1 visit (in-person)
Electronic Gastroduodenoscopy (EGD) Examination
Duration - Within 24 hours post-capsule exam
Within 24 hours after the capsule gastroscopy, participants undergo an electronic gastroduodenoscopy (EGD) performed by experienced endoscopists who are blinded to the capsule results. Biopsies or treatments may be performed if necessary.
1 visit (in-person)
ACG Video Reading and Analysis
Duration - Up to study completion
The capsule gastroscopy videos are reviewed manually and with AI assistance by blinded readers to assess diagnostic accuracy and compare reading times.
Trial Site Locations
Total: 12 locations
1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510515
Actively Recruiting
2
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
4
Renhua People's Hospital
Shaoguan, Guangdong, China, 510515
Actively Recruiting
5
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 510515
Actively Recruiting
6
Pingshan People's Hospital
Shenzhen, Guangdong, China, 510515
Actively Recruiting
7
Zhuhai People's Hospital
Zhuhai, Guangdong, China, 510515
Actively Recruiting
8
Wuxi People's Hospital.
Wuxi, Jiangsu, China, 510515
Actively Recruiting
9
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 510515
Actively Recruiting
10
Mianyang Central Hospital
Mianyang, Sichuan, China, 510515
Actively Recruiting
11
Prince of Wales Hospital of Hong Kong
Hong Kong, Hong Kong, 999077
Actively Recruiting
12
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Not Yet Recruiting
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Research Team
X
Xiaobei Luo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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