[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581836":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":37,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Intervention Group","EXPERIMENTAL","Participants will undergo endoscopic ultrasound-guided drainage of pancreatic pseudocysts using the HANAROSTEN® HOT Plumber™ with Z-EUSIT™.",[13],"Device: HANAROSTEN® HOT Plumber™ with Z-EUSIT™",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","HANAROSTEN® HOT Plumber™ with Z-EUSIT™","An electrocautery-enhanced lumen-apposing metal stent designed for the drainage of pancreatic pseudocysts. The stent is delivered using a system that allows for single-step deployment without the need for guidewire exchanges or tract dilation.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Dongwook Oh, MD, PhD","STUDY_DIRECTOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Tae Jun Song, MD, PhD","CONTACT","82-2-3010-3914","82-10-27028163","medi01@naver.com",{"name":33,"role":28,"phone":34,"phoneExt":35,"email":36},"Yoonchan Lee, MD","82-2-3010-1397","82-10-86899097","ycrlee@gmail.com",[38],{"facility":5,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":20,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Seoul","05505","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},[50,51,52],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":33,"role":28,"phone":34,"phoneExt":35,"email":36},{"name":23,"role":53,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Tae Jun Song, MD","Professor",[58],{"name":59,"class":60},"M.I.Tech Co., Ltd.","UNKNOWN","100581836","efficacy-and-safety-of-hanarosten-hot-plumber-with-z-eusit-for-pancreatic-pseudocyst-drainage-100581836",false,"NCT06855485","Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage","A Prospective Single-Center Observational Study on the Evaluation of Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocysts Drainage","ZEUS","Inclusion Criteria:\n\n* Must be 18 years or older\n* Diagnosed with pancreatic or peripancreatic pseudocyst or walled-off necrosis (with less than 30% solid components)\n* Eligible for endoscopic ultrasound-guided drainage\n* Able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Pseudocysts with the following characteristics:\n* Immature pseudocyst\n* Cystic neoplasm\n* Pseudoaneurysm\n* Multiple pseudocysts requiring drainage\n* Uncontrolled coagulation disorders:\n* INR \\> 1.5\n* Platelet count \\\u003C 50,000\u002Fmm³\n* Other bleeding disorders\n* Ineligibility for EUS-guided drainage due to anatomical or technical reasons\n* History of anaphylactic reaction to stent materials\n* Pregnant or potentially pregnant women\n* Current participation in another clinical trial that may affect study outcomes","ALL","18 Years",{"count":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this prospective, single-center observational study is to evaluate the safety and effectiveness of the HANAROSTEN® HOT Plumber™ with Z-EUSIT™ for draining pancreatic pseudocysts.\n\nThe main questions the study aims to answer are:\n\n* Does the device reduce the size of pancreatic pseudocysts by at least 50% and improve associated symptoms within 30 to 60 days?\n* Can the stent be successfully placed, retained, and removed without complications?\n\nParticipants will:\n\n* Undergo endoscopic ultrasound-guided transgastric or transduodenal drainage of pancreatic pseudocysts using the HANAROSTEN® HOT Plumber™ with Z-EUSIT™.\n* Be monitored for adverse events such as bleeding, infection, stent migration, or tissue injury.\n* Return for follow-up visits within 30 or 60 days for stent removal and evaluation of clinical success.\n\nThe study will:\n\n* Enroll 20 adults aged 18 years or older who meet the inclusion criteria.\n* Conduct follow-up assessments until one month after stent removal.",[79],"Pancreatic Pseudocyst",[79,81,82,83],"Endosonography","Drainage","Stents","2025-02-27",{"date":86,"type":87},"2025-03-03","ACTUAL",{"date":89,"type":73},"2025-02-25",{"date":91,"type":73},"2025-12-30",{"name":5,"class":6},1]