A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorNanfang Hospital, Southern Medical University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Elderly cohort: Permanent residents of Guangzhou aged ≥60 years who have not undergone specialized gastric disease screening in the past three years;
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);
Disqualifiers
Not considered by the investigator to be suitable for participation in this study.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Collect epidemiological, diagnostic, and follow-up data after MCG examination.
Other interventionMCG System: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Enrolment Group1 intervention
Trial outcomes
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.
Time frame
At end of data collection phase (within 6 months of study launch)Secondary outcomes
1
Safety of MCG
This outcome tracks the incidence and types of adverse events related to the MCG procedure, including capsule retention, discomfort, or complications requiring medical intervention.
Time frame
Within 14days after MCG procedure2
Quality of MCG Examination
The coverage rate of gastric anatomical regions, the device failure rate, image quality, and mucosal visibility will be evaluated for all MCG examinations. Coverage for each anatomical region and overall gastric coverage will be calculated as: Coverage rate = Number of Regions Adequately Visualized / Total Number of Anatomical Regions The calculation formula for the incidence of device failure is as follows: Device failure rate = Number of Cases with Device Failure / Number of Cases. A three-level grading scale (excellent / good / poor) will be used to objectively assess the following imaging quality indicators: clarity, field of view, image stability, structural and detail resolution, stereoscopic perception, overall image impression, intragastric cleanliness, gastric lumen distension, and mucosal visualization.
Time frame
At end of data collection phase (within 6 months of study launch)3
Procedural Compliance and Completion Rate
This outcome evaluates the proportion of participants who successfully complete the MCG exam without technical failure or early termination.
Time frame
Immediately after MCG procedure4
Patient Satisfaction
Participant-reported satisfaction with the MCG procedure, assessed via structured survey covering aspects such as comfort and convenience.
Time frame
Immediately after MCG procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanfang Hospital, Southern Medical University
Lead sponsor
Guangzhou First People's Hospital
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov