Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios

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.

Conditions

• Gastric Lesion
• Gastritis
• Upper Gastrointestinal Bleeding (UGIB)
• Gastric Dysplasia
• Gastric Ulcer
• Gastric Neoplasms

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

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• Pingshan People's Hospital

  collaborator UNKNOWN

• Ganzhou People's Hospital

  collaborator UNKNOWN

• Wuxi People's Hospital

  collaborator OTHER

• Prince of Wales Hospital, Shatin, Hong Kong

  collaborator OTHER

• Longgang District People's Hospital of Shenzhen

  collaborator OTHER

• Mianyang Central Hospital

  collaborator OTHER

• Renhua People's Hospital

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-03

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China
• Hong Kong
• Italy

Study Locations