Mobile capsule gastroscopy for detecting stomach problems in older and high-risk people
Screening for Gastric Pathologies in Elderly and High-Risk Populations Using a Mobile Capsule Gastroscopy System: a Prospective, Multicenter, Population Based Cohort Study
This project will test if an AI-assisted swallowable camera (mobile capsule gastroscopy) can find stomach diseases in older adults and people at higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07032961 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort within a public gastric screening program that uses an AI-assisted mobile capsule gastroscopy (MCG) to image the stomach in community and hospital settings. Participants eligible by age or risk factors will swallow the capsule, and investigators will collect epidemiological, diagnostic, and post-MCG follow-up data. The protocol emphasizes feasibility, detection rates of gastric pathologies, and practical implementation at community health centers. Safety, patient tolerance, and referral pathways for positive findings will also be tracked.
Who should consider this trial
Good fit: Ideal candidates are permanent residents of Guangzhou aged 60 or older who have not had specialized gastric screening in the past three years, or people aged 45+ who meet specified high-risk criteria (e.g., prior H. pylori, chronic atrophic gastritis, family history of gastric cancer, heavy smoking/alcohol or high-salt diet).
Not a fit: People who are younger and low-risk, those who have had recent specialized gastric screening, or patients with contraindications to capsule ingestion (for example suspected GI obstruction) are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, MCG could allow earlier, less-invasive detection of gastric disease in older and high-risk populations and expand screening access outside specialized endoscopy units.
How similar studies have performed: Capsule endoscopy and AI-assisted image analysis have shown promise in other GI applications, but AI-assisted mobile capsule gastroscopy for community gastric screening is relatively new and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.Provision of written informed consent; 2.Participants of the 'Gastric Pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality', the following are the criteria for inclusion in this public welfare programme: 1. Elderly cohort: Permanent residents of Guangzhou aged ≥60 years who have not undergone specialized gastric disease screening in the past three years; 2. Or high-risk cohort: Individuals aged ≥45 years who meet at least one of the following risk criteria: 1. History of Helicobacter pylori infection (positive ¹³C/¹⁴C urea breath test); 2. Prior diagnosis of chronic atrophic gastritis, gastric ulcer, neoplastic gastric polyps, hypertrophic gastritis, or pernicious anemia; 3. Family history of gastric cancer (first-degree relative with a confirmed diagnosis); 4. Long-term high-salt diet, smoking history (≥20 pack-years), or heavy alcohol consumption (100 mL of distilled spirits/day). Exclusion Criteria: 1. Not considered by the investigator to be suitable for participation in this study. 2. Meets the exclusion criteria of the Public Welfare Programme. Individuals will be excluded if they meet any of the following conditions: (1)Known allergy to medical polymer materials; (2)Psychiatric disorders that interfere with procedural cooperation; (3)Pregnancy or lactation; (4)Severe systemic comorbidities (e.g., cardiovascular, respiratory, neurological diseases) affecting examination tolerance; (5)Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or gastrointestinal diverticulosis; (6)Known or suspected gastrointestinal malformations, obstructions, strictures, or fistulas; (7)Clinically significant dysphagia; (8)Acute abdominal symptoms (e.g., pain, vomiting, suspected bowel obstruction, or severe constipation); (9)History of major gastrointestinal surgery (e.g., esophagogastrostomy, gastrojejunostomy); (10)Physical debilitation precludes postural changes or concurrent severe illness; (11)Medically ineligible for abdominal procedures or refusal to undergo them; (12)Deemed unsuitable for MCG by the investigator; (13)Refusal to provide informed consent; (14)Any other condition judged by the investigator to make the individual unsuitable for study participation.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (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.