Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
A Multicenter, Prospective Study of Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios
1 other identifier
interventional
482
3 countries
12
Brief Summary
The goal of this clinical trial is to evaluate the diagnostic accuracy of the AI-integrated Capsule Gastroscopy (ACG) system in simulated home-use conditions for detecting upper gastrointestinal (UGI) abnormalities. It will also compare the diagnostic accuracy and time efficiency of AI-assisted interpretation versus manual reading of ACG data. The main questions it aims to answer are: What is the diagnostic accuracy of the ACG system, using conventional esophagogastroduodenoscopy (EGD) as a standard of reference? Does AI-assisted ACG reading improve diagnostic accuracy or reduce reading time compared to manual ACG video reading? Researchers will compare ACG results to conventional EGD findings (standard of reference) to determine if ACG can serve as a reliable method for UGI disease detection in home scenarios. Participants will: Undergo an ACG examination in a simulated home environment. Complete an EGD procedure within 24 hours post-ACG ingestion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
March 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 9, 2025
July 1, 2025
1.8 years
February 12, 2025
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of ACG in screening for common UGI abnormalities
EGD will serve as the reference standard. Metrics such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, diagnostic agreement rate, positive agreement rate (PAR), negative agreement rate (NAR), and diagnostic agreement rate of each individual lesion will be calculated. A participant will be classified as positive if any lesions are detected, including but not limited to: chronic atrophic gastritis, gastric ulcer, gastric polyps, gastric dysplasia, gastric masses, gastric cancer, gastric hemorrhage and other gastric lesions. Esophageal abnormalities (reflux esophagitis, Barrett's esophagus, esophageal cancer, esophageal masses and other abnormalities), duodenal abnormalities (duodenal ulcer, duodenal polyps, hemorrhage and other abnormalities). If no lesions are detected, or only chronic superficial gastritis is observed, the participant will be classified as negative.
Through study completion, an average of 1 year.
Secondary Outcomes (13)
Diagnostic accuracy and average diagnostic time between AI-assisted reading and manual reading of ACG
Through study completion, an average of 1 year.
Coverage rate of gastric anatomical sites of ACG
Through study completion, an average of 1 year.
Inspection completion rate of ACG
Through study completion, an average of 1 year.
Average duration of ACG
Through study completion, an average of 1 year.
Average inspection time of ACG
Through study completion, an average of 1 year.
- +8 more secondary outcomes
Other Outcomes (1)
Safety evaluation
Through study completion, an average of 1 year.
Study Arms (2)
Testing Group
EXPERIMENTALProduct name: Gastric Capsule Endoscope System Specification model: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd. Participants fast for at least 8 hours and take mucolytics and anti-foaming agents 30 minutes before the ACG. Following video instructions, they connect the capsule with mobile, activate the capsule, and swallow it with water. Participants remain blinded to real-time ACG video. Researchers observe and record whether the participants have completed the examination as instructed in the video and any adverse events (without guidance). Data will be uploaded post-exam via WiFi or the manufacturer's system. Capsule discharge will be tracked.
Control group
ACTIVE COMPARATORProduct name: Electronic gastrointestinal endoscope (EGD) Specifications and models: GIF-290 series Manufacturer: Olympus, Tokyo, Japan EGD was the reference standard against which ACG was compared, and it was performed within 24 hours post-ACG ingestion time. Participants will fast for at least 8 hours (clear water is allowed) and take mucolytics and anti-foaming agents 30 minutes before the EGD. The EGD will then be performed by endoscopists with more than 500 EGD procedures completed, who are blinded to the ACG examination results. The procedure for this study will adhere to the Systematic Screening Protocol for the Stomach (SSS), as outlined by Yao et al(8).The endoscopists will record any lesions identified (including lesion type, location, size, number of lesions etc.), and biopsies or treatments will be performed following white-light EGD screening, if necessary. Anonymous reports, images, and videos will be exported for further analysis.
Interventions
Product name: Gastric Capsule Endoscope System Specification model: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.
EGD was the reference standard against which ACG was compared, and it was performed within 24 hours post-ACG ingestion time. Product name: Electronic gastrointestinal endoscope (EGD) Specifications and models: GIF-290 series Manufacturer: Olympus, Tokyo, Japan
Eligibility Criteria
You may qualify if:
- Aged 18 years or older.
- Individuals meeting the following criteria:
- i. Healthy volunteers; ii. Suspected presence of gastrointestinal diseases, with one or more of the following clinical symptoms: abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion; iii. Follow-up of gastric lesions post-endoscopic resection.
- Willing to participate voluntarily in the clinical trial and provide written informed consent.
- Capable of communicating with researchers and complying with trial requirements.
You may not qualify if:
- Pregnant individuals.
- Individuals at high risk of gastrointestinal obstruction, including those identified as being at risk of gastrointestinal stenosis based on the Gastrointestinal Stenosis Assessment Form, those in whom gastrointestinal obstruction cannot be clinically excluded, or individuals with a history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy.
- Individuals with swallowing dysfunction.
- Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
- Participants who are unable to comprehend and/or comply with physician instructions during the examination.
- Individuals with other medical risks that contraindicate the use of a capsule gastric endoscopy system, or those deemed unsuitable for participation in this study at the discretion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Fondazione Poliambulanza Istituto Ospedalierocollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
- Second Affiliated Hospital of Guangzhou Medical Universitycollaborator
- ZhuHai Hospitalcollaborator
- Pingshan People's Hospitalcollaborator
- Ganzhou People's Hospitalcollaborator
- Wuxi People's Hospitalcollaborator
- Prince of Wales Hospital, Shatin, Hong Kongcollaborator
- Longgang District People's Hospital of Shenzhencollaborator
- Mianyang Central Hospitalcollaborator
- Renhua People's Hospitalcollaborator
Study Sites (12)
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510515, China
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510515, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Renhua People's Hospital
Shaoguan, Guangdong, 510515, China
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, 510515, China
Pingshan People's Hospital
Shenzhen, Guangdong, 510515, China
Zhuhai People's Hospital
Zhuhai, Guangdong, 510515, China
Wuxi People's Hospital.
Wuxi, Jiangsu, 510515, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 510515, China
Mianyang Central Hospital
Mianyang, Sichuan, 510515, China
Prince of Wales Hospital of Hong Kong
Hong Kong, 999077, Hong Kong
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124, Italy
Related Publications (8)
Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
PMID: 24714327RESULTSun Y, Zhang W, Gu J, Xia L, Cao Y, Zhu X, Wen H, Ouyang S, Liu R, Li J, Jiang Z, Cheng D, Lv Y, Han X, Qiu W, Cai K, Song E, Cao Q, Li L. Magnetically driven capsules with multimodal response and multifunctionality for biomedical applications. Nat Commun. 2024 Feb 29;15(1):1839. doi: 10.1038/s41467-024-46046-9.
PMID: 38424039RESULTHo AHY, Lui RN. The current and future clinical applications of capsule endoscopy. J Gastroenterol Hepatol. 2024 Jan;39(1):28-33. doi: 10.1111/jgh.16490. Epub 2024 Jan 18. No abstract available.
PMID: 38238541RESULTLai HS, Wang XK, Cai JQ, Zhao XM, Han ZL, Zhang J, Chen ZY, Lin ZZ, Zhou PH, Hu B, Li AM, Liu SD. Standing-type magnetically guided capsule endoscopy versus gastroscopy for gastric examination: multicenter blinded comparative trial. Dig Endosc. 2020 May;32(4):557-564. doi: 10.1111/den.13520. Epub 2019 Oct 10.
PMID: 31483889RESULTPinheiro G, Coelho PJS, Salgado M, Oliveira HP, Cunha A. Deep Homography Based Localization on Videos of Endoscopic Capsules. 2018 IEEE International Conference on Bioinformatics and Biomedicine (BIBM). 2018:724-7.
RESULTNeumann H, Meier PN. Complications in gastrointestinal endoscopy. Dig Endosc. 2016 Jul;28(5):534-6. doi: 10.1111/den.12652. No abstract available.
PMID: 27397702RESULTWang FH, Zhang XT, Li YF, Tang L, Qu XJ, Ying JE, Zhang J, Sun LY, Lin RB, Qiu H, Wang C, Qiu MZ, Cai MY, Wu Q, Liu H, Guan WL, Zhou AP, Zhang YJ, Liu TS, Bi F, Yuan XL, Rao SX, Xin Y, Sheng WQ, Xu HM, Li GX, Ji JF, Zhou ZW, Liang H, Zhang YQ, Jin J, Shen L, Li J, Xu RH. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2021. Cancer Commun (Lond). 2021 Aug;41(8):747-795. doi: 10.1002/cac2.12193. Epub 2021 Jul 1.
PMID: 34197702RESULTJapanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25. doi: 10.1007/s10120-022-01331-8. Epub 2022 Nov 7.
PMID: 36342574RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2025
First Posted
February 27, 2025
Study Start
March 3, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 9, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share