A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening
Screening for Gastric Pathologies in Elderly and High-Risk Populations Using a Mobile Capsule Gastroscopy System: a Prospective, Multicenter, Population Based Cohort Study
Nanfang Hospital, Southern Medical University
10,000 participants
Jun 24, 2025
OBSERVATIONAL
Conditions
Summary
The goal of this is to learn about the effectiveness and feasibility of a novel AI- assisted Mobile Capsule Gastroscopy (MCG) system for detecting gastric pathologies in elderly and high-risk populations. The main question it aims to answer is: Can MCG effectively detect gastric pathologies, including common gastric diseases, gastric cancer, and precancerous lesions, in elderly and high-risk individuals at community health centers? Participants will: Epidemiological, diagnostic, and post-MCG follow-up data generated during participants' involvement in the gastric pathologies public screening program will be collected.
Eligibility
Inclusion Criteria7
- 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:
- Elderly cohort: Permanent residents of Guangzhou aged ≥60 years who have not undergone specialized gastric disease screening in the past three years;
- Or high-risk cohort: Individuals aged ≥45 years who meet at least one of the following risk criteria:
- History of Helicobacter pylori infection (positive ¹³C/¹⁴C urea breath test);
- Prior diagnosis of chronic atrophic gastritis, gastric ulcer, neoplastic gastric polyps, hypertrophic gastritis, or pernicious anemia;
- Family history of gastric cancer (first-degree relative with a confirmed diagnosis);
- Long-term high-salt diet, smoking history (≥20 pack-years), or heavy alcohol consumption (100 mL of distilled spirits/day).
Exclusion Criteria2
- Not considered by the investigator to be suitable for participation in this study.
- (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.
Interventions
MCG System: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.
Locations(1)
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NCT07032961