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Clinical Trials in China / NCT07032961
Recruiting Observational

A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening

NCT07032961 · tracked via the Priya Life Science China tracker
Sponsor
Nanfang Hospital, Southern Medical University
Phase
Observational
Started
2025-06-24
Last updated
2025-07-04

Condition(s) studied

GastritisGastric DysplasiaGastric UlcerGastric CancerGastric Mass

Investigational drug(s) / intervention(s)

Collect epidemiological, diagnostic, and follow-up data after MCG examination.

Collect epidemiological, diagnostic, and follow-up data after MCG examination.: MCG System: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.

Study 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

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07032961 on ClinicalTrials.gov ↗ ← All trials in China