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RECRUITING
NCT06848400
NA

Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Prospective Study of Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

482

Start Date

2025-03-03

Completion Date

2026-12-31

Last Updated

2025-07-09

Healthy Volunteers

Yes

Interventions

DEVICE

AI-integrated Capsule Gastroscopy (ACG) examination

Product name: Gastric Capsule Endoscope System Specification model: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.

DEVICE

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

Locations (12)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Renhua People's Hospital

Shaoguan, Guangdong, China

Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Pingshan People's Hospital

Shenzhen, Guangdong, China

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Wuxi People's Hospital.

Wuxi, Jiangsu, China

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Prince of Wales Hospital of Hong Kong

Hong Kong, Hong Kong

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy