NCT06848400 Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
| NCT ID | NCT06848400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Gastric Lesion |
| Study Type | INTERVENTIONAL |
| Enrollment | 482 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 482 participants in total. It began in 2025-03-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06848400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Lesion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06848400 currently recruiting?
Yes, NCT06848400 is actively recruiting participants. Contact the research team at luoxiaobei63@126.com for enrollment information.
Where is the NCT06848400 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Shaoguan, China and 8 additional locations.
Who is sponsoring the NCT06848400 clinical trial?
NCT06848400 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 482 participants.