AI-guided swallowable stomach camera for home-style screening
A Multicenter, Prospective Study of Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
NA · Nanfang Hospital, Southern Medical University · NCT06848400
This trial will test an AI-powered swallowable camera in adults to see if it can detect gastric problems as accurately and faster than manual reading by comparing it to standard gastroscopy in a simulated home setting.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 482 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 12 sites (Guangzhou, Guangdong and 11 other locations) |
| Trial ID | NCT06848400 on ClinicalTrials.gov |
What this trial studies
Researchers will give participants an AI-integrated capsule gastroscope to use in a simulated home environment and then perform a conventional esophagogastroduodenoscopy (EGD) within 24 hours as the reference standard. The study compares diagnostic accuracy of the capsule system against EGD and compares AI-assisted video reading to manual video reading for both accuracy and reading time. Participants follow standardized body-position changes to allow the capsule to image the stomach without magnetic guidance. The trial is prospective and enrolls adults who are healthy volunteers, symptomatic, or undergoing post‑resection follow-up.
Who should consider this trial
Good fit: Adults aged 18 or older who are healthy volunteers, have symptoms suggesting upper GI disease, or require follow-up after endoscopic resection and who can give consent and comply with study procedures are eligible.
Not a fit: People who are pregnant, at high risk for gastrointestinal obstruction, have a history suggesting possible obstruction or significant prior GI surgery, or who cannot safely swallow a capsule are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could offer a more comfortable, accessible way to screen for stomach diseases without needing specialized magnetic guidance or immediate invasive gastroscopy.
How similar studies have performed: Capsule endoscopy has established diagnostic use in parts of the GI tract and prior work shows promise, but AI-integrated, unguided capsule gastroscopy for simulated home use is a relatively novel application with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong and 11 other locations
- Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (RECRUITING)
- Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
- Renhua People's Hospital — Shaoguan, Guangdong, China (RECRUITING)
- Longgang District People's Hospital of Shenzhen — Shenzhen, Guangdong, China (RECRUITING)
- Pingshan People's Hospital — Shenzhen, Guangdong, China (RECRUITING)
- Zhuhai People's Hospital — Zhuhai, Guangdong, China (RECRUITING)
- Wuxi People's Hospital. — Wuxi, Jiangsu, China (RECRUITING)
- Ganzhou People's Hospital — Ganzhou, Jiangxi, China (RECRUITING)
- Mianyang Central Hospital — Mianyang, Sichuan, China (RECRUITING)
- Prince of Wales Hospital of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
- Fondazione Poliambulanza Istituto Ospedaliero — Brescia, Italy (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Xiaobei Luo
- Email: luoxiaobei63@126.com
- Phone: +86 17688881428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Lesion, Gastritis, Upper Gastrointestinal Bleeding, Gastric Dysplasia, Gastric Ulcer, Gastric Neoplasms, upper gastrointestinal diseases, Capsule Endoscopy