Status:
RECRUITING
A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Guangzhou First People's Hospital
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Gastritis
Gastric Dysplasia
Eligibility:
All Genders
45+ years
Brief 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 populati...
Detailed Description
Gastric diseases-including atrophic gastritis, gastric polyps, peptic ulcers, submucosal lesions, gastric cancer, and precancerous conditions-have become a major global public health challenge. In Chi...
Eligibility 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:
-
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 Criteria:
- Not considered by the investigator to be suitable for participation in this study.
- 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.
Key Trial Info
Start Date :
June 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2030
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT07032961
Start Date
June 24 2025
End Date
October 31 2030
Last Update
July 4 2025
Active Locations (1)
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1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515