Clinical trial · Interventional
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
NCT06848400CI-TRIAL-00091920recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Dysplasia | — | UNRESOLVED | — |
| Gastric Lesion | — | UNRESOLVED | — |
| Gastric Neoplasms | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastric Ulcer | — | UNRESOLVED | — |
| Gastritis | — | UNRESOLVED | — |
| Upper Gastrointestinal Bleeding (UGIB) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-integrated Capsule Gastroscopy (ACG) examination | Device | — | UNRESOLVED |
| Electronic gastroduodenoscopy (EGD) examination | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Testing Group
- description
- Product 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.
- interventionNames
- Device: AI-integrated Capsule Gastroscopy (ACG) examination
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Product 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Aged 18 years or older. 2. 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. 3. Willing to participate voluntarily in the clinical trial and provide written informed consent. 4. Capable of communicating with researchers and complying with trial requirements. Exclusion criteria 1. Pregnant individuals. 2. 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. 3. Individuals with swallowing dysfunction. 4. Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures. 5. Participants who are unable to comprehend and/or comply with physician instructions during the examination. 6. 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.
References
Publications (8)
- RESULTYao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22. PMID 24714327
- RESULTSun 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 38424039
- RESULTHo 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 38238541
- RESULTLai 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 31483889
- RESULTPinheiro 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 27397702
- RESULTWang 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.