[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582813":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":44,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":106,"collaborators":108,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":25,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":25,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Hutom Corp","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Operative time","The duration of time between starting a surgical incision to the last sutures of the operation.","The operative day (operative day ± 5 days)",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Tumor and vessel identification time","The duration of time between starting manipulation of the surgeon console to the finishing dissection of the hilum and perinephric fat",{"measure":18,"description":19,"timeFrame":20},"Resection volume","Calculated from the 3-dimensional lengths from the resected renal specimen using ellipsoid formula (π\u002F6XYZ)","From the postoperative 1week to the postoperative 5 weeks",{"measure":22,"description":23,"timeFrame":24},"Postoperative complications","Incidence of postoperative complications occurred within 4 weeks after the operation. The complications include urine leak, acute kidney injury, renal hemorrhage, fluid collection, abscess, and pulmonary or cardiac complications.","From the postoperative 8 weeks to the postoperative 16 weeks",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Experimental Group","EXPERIMENTAL","Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE.",[39],"Device: RUS NE",{"label":41,"type":42,"description":43,"interventionNames":25},"Control arm","NO_INTERVENTION","Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE.",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":25},"DEVICE","RUS NE","The RUS NE is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the intra-abdominal surgical environments, allowing for the visualization of tumor, vascular structures and intra-abdominal organs during the surgical planning process and the operation. RUS NE utilizes preoperative CT images of the patients to segment tumor, organs, and blood vessels and reconstructs them into a 3D model. Although there is no direct intervention on the patient, the surgeon uses RUS NE as a surgical navigation tool to simulate the surgery before performing the actual procedure.",[35],[51],{"name":52,"affiliation":53,"role":54},"Cheryn Song, M.D.,Ph.D.","Asan Medical Center","PRINCIPAL_INVESTIGATOR",[56,60],{"name":52,"role":57,"phone":58,"phoneExt":25,"email":59},"CONTACT","82-2-3010-5992","cherynsong@amc.seoul.kr",{"name":61,"role":57,"phone":62,"phoneExt":25,"email":63},"Suh Min Kim, M.D.,Ph.D.","82-2-6956-0426","smkim@hutom.co.kr",[65,76,86,96],{"facility":66,"status":67,"city":68,"state":69,"zip":25,"country":70,"countryCode":25,"cosmosGeoPoint":25,"geoPoint":25,"contacts":71},"Chonnam National University Hospital","RECRUITING","Kwangju","Jeollanam-do","South Korea",[72],{"name":73,"role":57,"phone":74,"phoneExt":25,"email":75},"Eu Chang Hwang","82-61-379-7114","urohwang@gmail.com",{"facility":53,"status":67,"city":77,"state":25,"zip":25,"country":70,"countryCode":25,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Seoul",{"type":79,"coordinates":80},"Point",[81,82],126.9784,37.566,{"lat":82,"lon":81},[85],{"name":52,"role":57,"phone":25,"phoneExt":58,"email":59},{"facility":87,"status":67,"city":77,"state":25,"zip":25,"country":70,"countryCode":25,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Samsung Medical Center",{"type":79,"coordinates":89},[81,82],{"lat":82,"lon":81},[92],{"name":93,"role":57,"phone":94,"phoneExt":25,"email":95},"minyong Kang","82-2-3410-1138","dr.minyong.kang@gmail.com",{"facility":97,"status":67,"city":77,"state":25,"zip":25,"country":70,"countryCode":25,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Severance Hospital",{"type":79,"coordinates":99},[81,82],{"lat":82,"lon":81},[102],{"name":103,"role":57,"phone":104,"phoneExt":25,"email":105},"Lee","82-2-2228-1004","LEESEH@yuhs.ac",{"type":107,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[109,111,113,114,115,117],{"name":53,"class":110},"OTHER",{"name":112,"class":110},"Seoul National University Hospital",{"name":87,"class":110},{"name":66,"class":110},{"name":116,"class":110},"Kyungpook National University Hospital",{"name":97,"class":110},"100582813","a-multicenter-study-of-rus-ne-100582813",false,"NCT06868186","A Multicenter Study of RUS NE","A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy","Inclusion Criteria:\n\n* Individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy\n* The diameter of renal tumor is 7cm or below\n* Individuals aged between 19 and 80\n* Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form\n\nExclusion Criteria:\n\n* Individuals with solitary kidney or horseshoe kidney\n* Individuals undergo bilateral nephrectomy\n* Individuals undergo operation other than partial nephrecotmy\n* Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes\n* Individuals with severe chronic kidney disease (eGFR \\\u003C 45, calculated with EPI-CKI equation)\n* Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI\n* Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study\n* Individuals who were participated in other clinical study within 4 weeks of screening\n* Individuals who are thought to be inappropriate to participate to the clinical trial by the investigators","ALL","19 Years","80 Years",{"count":129,"type":130},204,"ESTIMATED","INTERVENTIONAL",[133],"NA","This sponsor-initiated, randomized controlled clinical trial aims to demonstrate the clinical efficacy of RUS NE Surgical Navigation System in patients undergoing robotic-assisted partial nephrectomy. The trial will compare the experimental group (n=102) using RUS NE with a control group (n=102), aiming to show an 10% reduction in operation time. The study will involve 6 medical centers in South Korea in patient recruitment and evaluate the clinical efficacy and feasibility of the software, which has been shown to be reliable in previous studies.\n\n* Investigational Medical Device: RUS NE (Endoscopic Imaging Treatment Planning Software)\n* Clinical Trial duration: 24 months from IRB approval -Target number of subjects: Total of 204 participants",[136],"Renal Tumors",[138,139,140,141],"renal tumor","robot assisted partial nephrectomy","3D model","surgical navigation","2025-09-10",{"date":144,"type":145},"2025-09-11","ACTUAL",{"date":147,"type":145},"2025-04-29",{"date":149,"type":130},"2026-04-30",{"name":5,"class":6},4]