ClinConnect ClinConnect Logo
Search / Trial NCT07032961

A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jun 23, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Capsule Endoscopy Prospective Study Screening

ClinConnect Summary

This clinical trial is studying a new way to check for stomach problems, including common conditions like inflammation, ulcers, and even stomach cancer, using a small, swallowable camera called a Mobile Capsule Gastroscopy (MCG). This camera is assisted by artificial intelligence (AI) to help doctors spot any issues more easily. The study focuses on older adults and people at higher risk for stomach diseases to see if this method works well in community health centers.

People who might join the study are those aged 60 or older living in Guangzhou who haven’t had a stomach screening in the past three years, or individuals 45 and older who have certain risk factors like a history of stomach infections, family history of stomach cancer, or lifestyle habits such as smoking or heavy drinking. Participants will swallow the capsule, which will capture images of their stomach, and the study team will collect information before and after this screening to understand how well the test works. The trial is not yet recruiting, and anyone interested should meet the health and safety criteria set by the researchers to ensure the test is safe and suitable for them.

Gender

ALL

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.

About Nanfang Hospital, Southern Medical University

Nanfang Hospital, affiliated with Southern Medical University, is a leading medical institution in China renowned for its comprehensive clinical services and commitment to advancing healthcare through research and education. As a clinical trial sponsor, Nanfang Hospital leverages its state-of-the-art facilities and a multidisciplinary team of expert researchers to conduct innovative studies aimed at improving patient outcomes and contributing to the global medical community. The hospital's focus on ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and scientific rigor.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported