[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640767":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Affiliated Hospital to Academy of Military Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Novel Clip-Assisted Traction ESD\u002FEFTR","EXPERIMENTAL","Patients will undergo ESD or EFTR using the \"clip with line\" traction method with the novel two-tooth clip. After initial circumferential mucosal incision, the two-tooth clip (with pre-tied line) will be anchored to the lesion. The endoscopist will apply continuous or intermittent traction via the line to optimize the submucosal view. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips in a purse-string configuration.",[13],"Device: A Novel Two-Tooth Endoscopic Clip",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional ESD\u002FEFTR","ACTIVE_COMPARATOR","Patients will undergo standard ESD or EFTR without the use of dedicated traction devices. The endoscopist may use transparent cap assistance and positional changes for exposure, which is current standard practice.",[19],"Device: Clip",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","A Novel Two-Tooth Endoscopic Clip","\"Clip with line\" traction method with the novel two-tooth clip will be applied in patients undergoing ESD or EFTR. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Clip","Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure.",[15],[32],{"name":33,"affiliation":34,"role":35},"Yan Liu, M.D.,Ph.D.","Beijing 302 Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Min Min, M.D., Ph.D.","CONTACT","+86-010-66947473","minmin823@sina.com",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Yan Liu, M.D., Ph.D.","13911798288@163.com",[46],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":26},"The Fifth Medical Center of Chinese PLA General Hospital","RECRUITING","Beijing","100071","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640767","a-novel-two-tooth-clip-for-esd-and-eftr-of-gist-100640767",false,"NCT07581977","A Novel Two-Tooth Clip for ESD and EFTR of GIST","Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 85 years.\n* Patients diagnosed with gastric gastrointestinal lesions clinically indicated for ESD or EFTR.\n* Lesion size between 2 cm and 5 cm in diameter.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Lesions with clear evidence of deep submucosal invasion or distant metastasis precluding curative endoscopic resection.\n* Severe coagulation dysfunction (international normalized ratio \\>2.0, platelet count \\\u003C50,000\u002FµL) or ongoing use of dual antiplatelet therapy\u002Fanticoagulants that cannot be appropriately bridged or discontinued per guidelines.\n* Severe organ failure (cardiac, renal, hepatic, or respiratory) rendering the patient unsuitable for prolonged sedation or general anesthesia.\n* Pregnancy or lactation.\n* Prior surgical or endoscopic intervention at the target lesion site that results in significant fibrosis.","ALL","18 Years","85 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study is designed to evaluate the efficacy and safety of a novel two-tooth endoscopic clip, utilized in a \"clip with line\" traction configuration, during endoscopic resection procedures (ESD and EFTR) of GIST. The novel clip's dual-tooth design is intended to provide a more secure anchor on the lesion, enabling effective counter-traction when combined with a line. The primary aim is to determine if this method improves submucosal dissection efficiency compared to conventional ESD. A secondary aim is to evaluate the performance of the same clip system for full-thickness or mucosal defect closure.",[79],"GIST - Gastrointestinal Stromal Tumor",[81,82,83,84],"GIST","ESD","EFTR","two-tooth clips","2026-05-20",{"date":87,"type":88},"2026-05-22","ACTUAL",{"date":90,"type":88},"2026-04-24",{"date":92,"type":73},"2027-07-01",{"name":5,"class":6},1]