Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into a new way to check for stomach problems using a special capsule called the AI-integrated Capsule Gastroscopy (ACG). The main goal is to see how well this capsule works at finding issues in the upper part of the digestive system, like ulcers or inflammation, when used at home. Researchers want to find out if using artificial intelligence (AI) to read the results from the capsule is better or faster than having a doctor read them manually. To do this, they will compare the capsule’s findings to those from a traditional procedure called esophagogastroduodenoscopy (EGD), which is a more standard way to look inside the stomach.

To participate in this trial, you need to be at least 18 years old and may have symptoms like stomach pain, nausea, or recent changes in your digestion. Participants will first swallow the capsule at home and then have an EGD within 24 hours to compare results. However, there are some people who cannot join, such as those who are pregnant, have certain swallowing issues, or have had certain surgeries. If you’re interested and meet the criteria, you’ll be contributing to important research that could help improve how stomach conditions are diagnosed.

Gender

ALL

Eligibility criteria

• • 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.