RecruitingNot ApplicableNCT06848400

Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

482 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a swallowable capsule camera (capsule endoscopy) can effectively screen for stomach diseases in a simulated home setting — potentially making stomach examinations more accessible without needing a traditional hospital scope procedure. **You may be eligible if...** - You are 18 years of age or older - You are a healthy volunteer, OR - You have symptoms that suggest a possible gastrointestinal problem, such as stomach pain, nausea, vomiting, vomiting blood, black or bloody stools, loss of appetite, weight loss, difficulty swallowing, or heartburn - You are willing to follow the preparation and capsule swallowing protocol **You may NOT be eligible if...** - You have a known blockage or narrowing in your digestive tract - You have a condition that makes swallowing a capsule dangerous - You have an implanted pacemaker or other device that could interfere with the capsule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAI-integrated Capsule Gastroscopy (ACG) examination

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

DEVICEElectronic 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

View Full Details on ClinicalTrials.gov

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NCT06848400


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