[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641474":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":41,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":26},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RG（Robot group）","EXPERIMENTAL","1.Marking and mucosal incision.2.Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.3.Perform meticulous dissection along the capsule-muscular layer interface using an ESD knife, and preserve the integrity of the serosa as much as possible.4.En bloc resection and removal of the tumor.5.Verification of serosal integrity: The procedure can be completed only if air\u002Fwater insufflation test shows negative results. Mucosal defects are closed by standard techniques.",[13],"Device: Robot system",{"label":15,"type":16,"description":17,"interventionNames":18},"TG（Traditional Group）","ACTIVE_COMPARATOR","The procedures are performed by surgeons of equivalent seniority via conventional endoscopic full-thickness resection (EFTR) or modified endoscopic submucosal dissection (modified ESD). If a safe dissection plane cannot be established, full-thickness incision is conducted followed by closure using over-the-scope clip (OTSC), covered stent or suturing techniques. Leakage is assessed and managed in accordance with standard protocols.",[19],"Device: Non-robotic conventional endoscopy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Robot system","After Marking and mucosal incision，Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Non-robotic conventional endoscopy","Conventional endoscopy without Robot",[15],[32],{"name":33,"affiliation":5,"role":34},"Rui Li","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Chenhuan Tan","CONTACT","+86 18860928860","tanchenhuan2013@163.com",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100641474","endofaster-robot-for-gastroesophageal-submucosal-tumors-a-randomized-controlled-study-100641474",false,"NCT07655674","Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study","Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study","Inclusion Criteria:\n\n1. Aged 18 to 80 years old;\n2. Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);\n3. Tumor diameter ranging from 1.0 cm to 3.0 cm;\n4. No active ulcer or bleeding on the lesion surface before operation;\n5. American Society of Anesthesiologists (ASA) physical status class I-III;\n6. Voluntarily signed written informed consent.\n\nExclusion Criteria:\n\n1. Tumor adhesion to serosa with unclear interface shown on EUS;\n2. High-risk GIST or distant metastasis indicated by imaging or endoscopy;\n3. History of gastric surgery or radiotherapy;\n4. High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;\n5. Pregnant or breastfeeding women;\n6. Failure to cooperate with follow-up.","ALL","18 Years","80 Years",{"count":54,"type":55},110,"ESTIMATED","INTERVENTIONAL",[58],"NA","In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?",[61],"Gastric Submucosal Tumors",[63,64],"gastric submucosal tumors","Robotic endoscope","NOT_YET_RECRUITING","2026-06-17",{"date":68,"type":69},"2026-06-18","ACTUAL",{"date":71,"type":55},"2026-07-01",{"date":73,"type":55},"2028-06-30",{"name":5,"class":6}]