Actively Recruiting
Screening for Gastric Pathologies in Elderly and High-Risk Populations Using a Mobile Capsule Gastroscopy System: a Prospective, Multicenter, Population Based Cohort Study
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-07-04
10000
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
G
Guangzhou First People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new AI-assisted Mobile Capsule Gastroscopy (MCG) system designed to detect various gastric diseases, including gastric cancer and precancerous lesions, in elderly and high-risk individuals. Gastric diseases pose a significant health challenge worldwide, especially in China, where gastric cancer has high incidence and mortality rates. Early detection through screening is crucial, as prompt treatment can greatly improve survival rates. This study aims to assess the effectiveness and practicality of MCG in community health centers for these populations. The MCG system includes a disposable capsule and a wireless portable receiver, allowing participants to complete the examination independently by following video instructions on a smartphone app and adjusting their body position to guide the capsule. An AI algorithm monitors gastric coverage in real time, and the video is accessible on the smartphone and can be uploaded for remote diagnosis. This non-invasive and user-friendly system does not require expensive magnetic navigation, making it suitable for widespread use in community settings. The study is part of a public health screening program targeting 10,000 elderly and high-risk residents. Participants will provide demographic and medical history data, undergo laboratory tests and MCG examination, and may receive esophagogastroduodenoscopy (EGD) and biopsies if needed. Short-term follow-up will monitor capsule excretion and any adverse events up to 14 days after MCG, while long-term follow-up will continue annually for five years to track gastric disease incidence and survival. Researchers will evaluate detection rates, safety, examination quality, patient satisfaction, and cost-effectiveness of the MCG system to inform future gastric disease prevention strategies.
CONDITIONS
Brief Title
A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be a participant in the 'Gastric Pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality'
- Be a permanent resident of Guangzhou aged 60 years or older without specialized gastric disease screening in the past three years
- Or be aged 45 years or older with at least one risk factor: history of Helicobacter pylori infection, prior diagnosis of certain gastric diseases, family history of gastric cancer, or lifestyle risks such as high-salt diet, smoking (20 or more pack-years), or heavy alcohol use (100 mL distilled spirits/day)
You will not qualify if you...
- Deemed unsuitable for study participation by the investigator
- Known allergy to medical polymer materials
- Psychiatric disorders interfering with cooperation
- Pregnancy or breastfeeding
- Severe systemic diseases affecting exam tolerance
- Inflammatory bowel disease or gastrointestinal diverticulosis
- Known or suspected gastrointestinal malformations, obstructions, strictures, or fistulas
- Significant difficulty swallowing
- Acute abdominal symptoms such as pain, vomiting, or severe constipation
- History of major gastrointestinal surgery
- Physical inability to change body position or severe illness
- Medically ineligible for abdominal procedures or refusal to undergo them
- Refusal to provide informed consent
- Any other condition judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 6 months
Participants undergo mobile-controlled capsule gastroscopy (MCG) to screen for gastric pathologies, with data collection on examination quality and capsule expulsion. Additional diagnostic procedures such as esophagogastroduodenoscopy (EGD) and biopsies may occur if indicated.
1 visit for MCG examination and possible additional diagnostic assessments
Duration - 14 days
Participants are followed up shortly after the MCG procedure to monitor capsule expulsion, adverse events, and referral outcomes, including clinical evaluation if capsule retention occurs.
3 follow-up contacts on Days 1, 3, and 14 post-MCG (phone or in-person)
Duration - 5 years
Participants are monitored annually to collect data on the incidence of gastric pathologies and survival outcomes over five years.
Annual telephone interviews and/or routine visits at community health centers
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
X
Xiaobei Luo
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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