NCT06848400Completed
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 482 (actual)
- First submitted
- 12 Feb 2025
- Start date
- 3 Apr 2025
- Primary completion date
- 18 Feb 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06848400
What you commit to
- Study type: Interventional
- Participants enrolled: 482
- From 3 Apr 2025 to the primary completion date, 18 Feb 2026
- 12 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
Other illness
- 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.
Other
- Pregnant individuals.
- Individuals with swallowing dysfunction.
- Participants who are unable to comprehend and/or comply with physician instructions during the examination.
- 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.
Who the study is looking for
- Aged 18 years or older.
- Individuals meeting the following criteria:
- 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.
- Willing to participate voluntarily in the clinical trial and provide written informed consent.
- Capable of communicating with researchers and complying with trial requirements.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ganzhou People's Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Mianyang Central Hospital Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Renhua People's Hospital Coordinator of this site? Confirm its status | Shaoguan | China | Unknown status |
| Longgang District People's Hospital of Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Pingshan People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Zhuhai People's Hospital Coordinator of this site? Confirm its status | Zhuhai | China | Unknown status |
| Prince of Wales Hospital of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Fondazione Poliambulanza Istituto Ospedaliero Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.