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.

Eligibility

Inclusion criteria

1. Aged 18 years or older.
2. Individuals meeting the following criteria:

   i. Healthy volunteers; ii. Suspected presence of gastrointestinal diseases, with one or more of the following clinical symptoms: abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion; iii. Follow-up of gastric lesions post-endoscopic resection.
3. Willing to participate voluntarily in the clinical trial and provide written informed consent.
4. Capable of communicating with researchers and complying with trial requirements.

Exclusion criteria

1. Pregnant individuals.
2. Individuals at high risk of gastrointestinal obstruction, including those identified as being at risk of gastrointestinal stenosis based on the Gastrointestinal Stenosis Assessment Form, those in whom gastrointestinal obstruction cannot be clinically excluded, or individuals with a history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy.
3. Individuals with swallowing dysfunction.
4. Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
5. Participants who are unable to comprehend and/or comply with physician instructions during the examination.
6. Individuals with other medical risks that contraindicate the use of a capsule gastric endoscopy system, or those deemed unsuitable for participation in this study at the discretion of the investigator.

Conditions7

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