A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening

NCT07032961 | Recruiting DMC

• 1 other identifier: NFEC-2025-276
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gastritis; Gastric Dysplasia; Gastric Ulcer; Gastric Cancer; Gastric Mass

Keywords

Capsule Endoscopy; Prospective Study; screening

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Gastric Diseases Using Mobile Capsule Gastroscopy

  This measure assesses the proportion of participants in whom MCG identifies common gastric diseases, gastric cancer, or precancerous lesions.

  At end of data collection phase (within 6 months of study launch)

Secondary Outcomes (6)

• Safety of MCG

  Within 14days after MCG procedure

• Quality of MCG Examination

  At end of data collection phase (within 6 months of study launch)

• Procedural Compliance and Completion Rate

  Immediately after MCG procedure

• Patient Satisfaction

  Immediately after MCG procedure

• Cost-Effectiveness of MCG Screening

  At end of data collection phase (within 6 months of study launch)

Study Arms (1)

Enrolment Group

The enrolment group includes all subjects who will undergo MCG examination in the 'Gastric pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality'.

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

Interventions

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

MCG System: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.

Enrolment Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10,000 participants enrolled in the existing public welfare screening program: Gastric Pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Guangzhou First People's Hospital: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Gastritis; Stomach Ulcer; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Xiaobei Luo

CONTACT

+86 17688881428; luoxiaobei63@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 24, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2030
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)