Mobile capsule gastroscopy for detecting stomach problems in older and high-risk people

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Xiaobei Luo
• Email: luoxiaobei63@126.com
• Phone: +86 17688881428

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.