What is this study trying to find out about gastric diseases?

This study aims to evaluate how well a new AI-assisted Mobile Capsule Gastroscopy (MCG) system can detect gastric diseases, including cancer and precancerous lesions, in elderly and high-risk people. It also looks at the system's safety and feasibility in community health centers. The research is led by Nanfang Hospital, Southern Medical University, to improve early detection and treatment strategies.

Who may be eligible for this gastric disease clinical trial?

Adults aged 45 and older who are either permanent residents aged 60 or above without recent gastric screening or individuals aged 45 or older with risk factors like Helicobacter pylori infection, prior gastric conditions, family history of gastric cancer, or certain lifestyle risks may qualify. The study accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this gastric disease clinical trial?

Study-related care, including the MCG examination and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs that might arise.

Actively Recruiting

Age: 45Years +

All Genders

Healthy Volunteers

ID07032961

Mobile Capsule Gastroscopy to Detect Gastric Diseases in Elderly and High-Risk Adults A Large Prospective Study in Community Health Centers

Led by Nanfang Hospital, Southern Medical University · Updated on 2025-07-04

10000

Participants Needed

Research Sites

208 weeks

Total Duration

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

Age: 45Years +

All Genders

Healthy Volunteers

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

Research Team

Xiaobei Luo

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