[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581291":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":182,"collaborators":184,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":26,"eligibilityCriteria":207,"healthyVolunteers":208,"sex":209,"minAge":210,"maxAge":26,"enrollmentInfo":211,"targetDuration":26,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":225,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Testing Group","EXPERIMENTAL","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.",[13],"Device: AI-integrated Capsule Gastroscopy (ACG) examination",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","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.\n\nThe 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.",[19],"Device: Electronic gastroduodenoscopy (EGD) examination",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","AI-integrated Capsule Gastroscopy (ACG) examination","Product name: Gastric Capsule Endoscope System Specification model: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Electronic gastroduodenoscopy (EGD) examination","EGD was the reference standard against which ACG was compared, and it was performed within 24 hours post-ACG ingestion time.\n\nProduct name: Electronic gastrointestinal endoscope (EGD) Specifications and models: GIF-290 series Manufacturer: Olympus, Tokyo, Japan",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiaobei Luo","CONTACT","+86 17688881428","luoxiaobei63@126.com",[38,56,65,69,81,92,101,113,126,139,152,166],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Guangdong Provincial Hospital of Traditional Chinese Medicine","RECRUITING","Guangzhou","Guangdong","510515","China","CN",{"type":47,"coordinates":48},"Point",[49,50],113.25,23.11667,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":26},"Wentian Prof. Liu","8613590337916",{"facility":57,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Second Affiliated Hospital of Guangzhou Medical University",{"type":47,"coordinates":59},[49,50],{"lat":50,"lon":49},[62],{"name":63,"role":34,"phone":64,"phoneExt":26,"email":26},"Hui Prof. Yang","8615915822551",{"facility":5,"status":40,"city":41,"state":42,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":66,"geoPoint":68,"contacts":26},{"type":47,"coordinates":67},[49,50],{"lat":50,"lon":49},{"facility":70,"status":40,"city":71,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Renhua People's Hospital","Shaoguan",{"type":47,"coordinates":73},[74,75],113.58333,24.8,{"lat":75,"lon":74},[78],{"name":79,"role":34,"phone":80,"phoneExt":26,"email":26},"xiang prof. li","8613719703041",{"facility":82,"status":40,"city":83,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Longgang District People's Hospital of Shenzhen","Shenzhen",{"type":47,"coordinates":85},[86,87],114.0683,22.54554,{"lat":87,"lon":86},[90],{"name":91,"role":34,"phone":55,"phoneExt":26,"email":26},"Li Prof. Xiang",{"facility":93,"status":40,"city":83,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Pingshan People's Hospital",{"type":47,"coordinates":95},[86,87],{"lat":87,"lon":86},[98],{"name":99,"role":34,"phone":100,"phoneExt":26,"email":26},"Xiaofeng Prof. Wang","8613724310636",{"facility":102,"status":40,"city":103,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Zhuhai People's Hospital","Zhuhai",{"type":47,"coordinates":105},[106,107],113.56778,22.27694,{"lat":107,"lon":106},[110],{"name":111,"role":34,"phone":112,"phoneExt":26,"email":26},"xiaohong Prof. Xu","‭8613798199161‬",{"facility":114,"status":40,"city":115,"state":116,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Wuxi People's Hospital.","Wuxi","Jiangsu",{"type":47,"coordinates":118},[119,120],120.28857,31.56887,{"lat":120,"lon":119},[123],{"name":124,"role":34,"phone":125,"phoneExt":26,"email":26},"QIANG PROF. ZHAN","‭8613358111976‬",{"facility":127,"status":40,"city":128,"state":129,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Ganzhou People's Hospital","Ganzhou","Jiangxi",{"type":47,"coordinates":131},[132,133],114.9326,25.84664,{"lat":133,"lon":132},[136],{"name":137,"role":34,"phone":138,"phoneExt":26,"email":26},"chunping Prof. Zhu","8613262825862",{"facility":140,"status":40,"city":141,"state":142,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Mianyang Central Hospital","Mianyang","Sichuan",{"type":47,"coordinates":144},[145,146],104.68168,31.46784,{"lat":146,"lon":145},[149],{"name":150,"role":34,"phone":151,"phoneExt":26,"email":26},"xinhua PROF. ZHAO","8613980137212",{"facility":153,"status":40,"city":154,"state":26,"zip":155,"country":154,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Prince of Wales Hospital of Hong Kong","Hong Kong","999077","HK",{"type":47,"coordinates":158},[159,160],114.17469,22.27832,{"lat":160,"lon":159},[163],{"name":164,"role":34,"phone":165,"phoneExt":26,"email":26},"YUN WONG PROF. LAU","(852)35051411",{"facility":167,"status":168,"city":169,"state":26,"zip":170,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Fondazione Poliambulanza Istituto Ospedaliero","NOT_YET_RECRUITING","Brescia","25124","Italy","IT",{"type":47,"coordinates":174},[175,176],10.21472,45.53558,{"lat":176,"lon":175},[179],{"name":180,"role":34,"phone":26,"phoneExt":26,"email":181},"Cristiano Prof. Spada","cristiano.spada@unicatt.it",{"type":183,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[185,186,187,188,190,192,194,196,198,199,200],{"name":167,"class":6},{"name":39,"class":6},{"name":57,"class":6},{"name":189,"class":6},"ZhuHai Hospital",{"name":93,"class":191},"UNKNOWN",{"name":193,"class":6},"Ganzhou City People's Hospital",{"name":195,"class":6},"Wuxi People's Hospital",{"name":197,"class":6},"Prince of Wales Hospital, Shatin, Hong Kong",{"name":82,"class":6},{"name":140,"class":6},{"name":70,"class":191},"100581291","capsule-gastric-endoscopy-for-gastric-disease-screening-in-simulated-home-scenarios-100581291",false,"NCT06848400","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","Inclusion criteria\n\n1. Aged 18 years or older.\n2. Individuals meeting the following criteria:\n\n   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.\n3. Willing to participate voluntarily in the clinical trial and provide written informed consent.\n4. Capable of communicating with researchers and complying with trial requirements.\n\nExclusion criteria\n\n1. Pregnant individuals.\n2. 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.\n3. Individuals with swallowing dysfunction.\n4. Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.\n5. Participants who are unable to comprehend and\u002For comply with physician instructions during the examination.\n6. 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.",true,"ALL","18 Years",{"count":212,"type":213},482,"ESTIMATED","INTERVENTIONAL",[216],"NA","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:\n\nWhat is the diagnostic accuracy of the ACG system, using conventional esophagogastroduodenoscopy (EGD) as a standard of reference?\n\nDoes AI-assisted ACG reading improve diagnostic accuracy or reduce reading time compared to manual ACG video reading?\n\nResearchers 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.\n\nParticipants will:\n\nUndergo an ACG examination in a simulated home environment. Complete an EGD procedure within 24 hours post-ACG ingestion.",[219,220,221,222,223,224],"Gastric Lesion","Gastritis","Upper Gastrointestinal Bleeding (UGIB)","Gastric Dysplasia","Gastric Ulcer","Gastric Neoplasms",[226,227,228,229,230],"upper gastrointestinal diseases","Capsule Endoscopy","Prospective Study","Diagnostic accuracy","Upper Gastrointestinal abnormalities","2025-07-03",{"date":233,"type":234},"2025-07-09","ACTUAL",{"date":236,"type":234},"2025-03-03",{"date":238,"type":213},"2026-12-31",{"name":5,"class":6},12]