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:

  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.

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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510515