[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647885":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":7,"responsibleParty":27,"collaborators":29,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":7,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":7,"enrollmentInfo":44,"targetDuration":7,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":57,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":7},{"fullName":5,"class":6},"Olympus Corporation of the Americas","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction","Multi-hole anti-migration stent for biliary strictures produced by malignant neoplasms",[14],{"name":15,"affiliation":16,"role":17},"Ryan J Law, Doctor of Osteopathic Medicine","Mayo Clinic","PRINCIPAL_INVESTIGATOR",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Sharon Rabine","CONTACT","484-896-5000","sharon.rabine@olympus.com",{"name":25,"role":21,"phone":7,"phoneExt":7,"email":26},"Jewel Gill","Jewel.Gill@olympus.com",{"type":28,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[30,32],{"name":16,"class":31},"OTHER",{"name":33,"class":34},"M.I.Tech Co., Ltd.","UNKNOWN","100647885","the-hanarostent-multi-hole-biliary-stent-is-indicated-for-use-in-the-palliative-treatment-of-biliary-strictures-produced-by-malignant-neoplasms-and-the-study-is-to-demonstrate-clinical-safety-and-performance-of-the-multi-hole-stent-for-the-palliative-treatment-of-malignant-biliary-obstruction-100647885",false,"NCT07715240","The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.","Evaluation of the Clinical Safety and Performance of an Investigational Multi-Hole™ Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction","Inclusion Criteria:\n\n* Suspected or confirmed malignant non-hilar extrahepatic biliary obstruction including any of the following measures of biliary obstruction or patients undergoing neoadjuvant cancer treatment (chemotherapy and\u002For radiation) for malignant biliary obstruction\n\nClinical symptoms including (e.g., cholangitis, jaundice, pruritus, pale stools, and\u002For dark urine)\n\nBiochemical evidence (Tbili \\> 3mg\u002FdL)\n\nHigh quality imaging (e.g., ultrasound, CT, MRCP, or ERCP)\n\n≥ 18 years of age\n\nWilling and able to provide informed consent\n\nExclusion Criteria:\n\n* Participation in another investigational study within 90 days prior to consent\n\nIntrahepatic metastases that extensively involve both lobes of the liver\n\nPatients with a distal malignant biliary obstruction due to potential resectable disease\n\nStrictures that could not be traversed by the delivery system\n\nPerforation of any duct within the biliary tree\n\nPresence of a biliary self-expanding metal stent (SEMS), esophageal stent, or duodenal stent\n\nActive viral hepatitis\n\nLife expectancy of \\\u003C 3 months\n\nPatient has undergone (within 30 days prior to enrollment) or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources\n\nUnwilling or unable to comply with the follow-up schedule","ALL","18 Years",{"count":45,"type":46},66,"ESTIMATED","INTERVENTIONAL",[49],"NA","The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.",[52],"Biliary Strictures Caused by Malignant Neoplasms",[54,55,56],"Biliary Stent","Stent","Biliary Obstruction","NOT_YET_RECRUITING","2026-07-17",{"date":60,"type":61},"2026-07-21","ACTUAL",{"date":63,"type":46},"2026-10-31",{"date":65,"type":46},"2028-05-30",{"name":5,"class":6}]