Actively Recruiting
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
95 weeks
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
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.
CONDITIONS
Official Title
Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Healthy volunteers or individuals suspected of gastrointestinal diseases with symptoms such as abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion
- Individuals following up on gastric lesions after endoscopic resection
- Willing to voluntarily participate and provide written informed consent
- Able to communicate with researchers and follow trial 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
- Swallowing dysfunction
- Unfit for surgery or unwilling to undergo surgical procedures
- Unable to understand or comply with physician instructions during examination
- Other medical risks contraindicating capsule gastric endoscopy or deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
X
Xiaobei Luo
CONTACT
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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