[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548899":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":23,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":23,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":23,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Patients with Malignant Liver Tumors","EXPERIMENTAL","Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.",[13,14,15,16],"Device: Starwave Microwave Ablation System","Procedure: Microwave Ablation","Device: Ultrasound-CT fusion guidance system","Drug: Local anesthesia and Conscious sedation",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Starwave Microwave Ablation System","A microwave ablation system consisting of the Starwave™ microwave generator and a 13-gauge Starwave™ antenna. The generator has a maximum power output of 150W and is manufactured by STARmed Co., Ltd..",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"PROCEDURE","Microwave Ablation","Under fusion ultrasound guidance, one or two 13-gauge antennas are used to apply up to 150W of microwave energy to the tumor. Overlapping ablation is performed as needed to create an echogenic safety margin of 5-10 mm around the tumor. To prevent bleeding, the antenna is removed while applying energy (\"hot withdrawal\").",[9],{"type":19,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Ultrasound-CT fusion guidance system","Fusion imaging of real-time ultrasound and pre-acquired CT\u002FMRI will be used to guide the antenna placement and monitor the ablation process.",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":23},"DRUG","Local anesthesia and Conscious sedation","Local anesthesia (e.g., 2% Lidocaine) and conscious sedation (e.g., Fentanyl and Midazolam) will be administered to the patient during the procedure",[9],[39],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},"Hyun Hee Lee","CONTACT","82-2-2072-4177","redlion55@naver.com",[45],{"facility":5,"status":46,"city":47,"state":23,"zip":23,"country":48,"countryCode":23,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Seoul","South Korea",{"type":50,"coordinates":51},"Point",[52,53],126.9784,37.566,{"lat":53,"lon":52},[56,57],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},{"name":58,"role":59,"phone":23,"phoneExt":23,"email":23},"Jeong Min Lee, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Jeong Min Lee","Professor","100548899","clinical-effectiveness-of-microwave-ablation-using-starwave-microwave-generator-for-hepatic-malignancies-100548899",false,"NCT06426992","Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies","Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study","Inclusion Criteria:\n\n* Child-Pugh Class A or B\n* Patients with suspected hepatocellular carcinoma or residual\u002Frecurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered\n\nExclusion Criteria:\n\n* In cases where there are three or more malignant liver tumors\n* When the maximum size of the tumor exceeds 4 cm\n* Diffuse infiltrative type of cancer with unclear tumor boundaries\n* When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more\n* Severe liver failure (Child-Pugh Class C)\n* In cases of vascular invasion by malignant liver tumors\n* Severe coagulopathy (platelet count below 50,000\u002Fmm³ or INR prolonged by more than 50%)\n* In cases of multiple extrahepatic metastases\n* Situations where it is highly unlikely to obtain appropriate data for research purposes","ALL","20 Years","85 Years",{"count":74,"type":75},128,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.",[81],"Liver Malignant Tumors","2026-04-08",{"date":84,"type":85},"2026-04-13","ACTUAL",{"date":87,"type":85},"2024-04-30",{"date":89,"type":75},"2026-08-30",{"name":5,"class":6},1]