[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433876":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":115,"collaborators":20,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":20,"eligibilityCriteria":122,"healthyVolunteers":119,"sex":123,"minAge":124,"maxAge":20,"enrollmentInfo":125,"targetDuration":20,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"QualiMed Innovative Medizinprodukte GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Device Treated Group","OTHER","Treated with the study device, UNITY-B Biodegradable Balloon-Expandable Biliary Stent System.",[13],"Device: Biliary Duct Stenting",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Biliary Duct Stenting","UNITY-B Balloon-expandable Biodegradable Biliary Stent deployment in obstructed biliary ducts.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Hairol Azrin bin Othman, MD","CONTACT","60374919191","hairol@gmail.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Edwin Tan","60374911226","edwinbt@sunway.com.my",[32,52,58,78,93,100],{"facility":33,"status":34,"city":35,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Queen Mary Hospital","RECRUITING","Hong Kong","HK",{"type":38,"coordinates":39},"Point",[40,41],114.17469,22.27832,{"lat":41,"lon":40},[44,48],{"name":45,"role":24,"phone":46,"phoneExt":20,"email":47},"Tan To Cheung, MD","2255 3025","tantocheung@hotmail.com",{"name":49,"role":24,"phone":50,"phoneExt":20,"email":51},"Kai Yeung Martin Leung, BSc","2255 4848","kll39@hku.hk",{"facility":53,"status":54,"city":35,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":55,"geoPoint":57,"contacts":20},"The Prince of Wales Hospital","ENROLLING_BY_INVITATION",{"type":38,"coordinates":56},[40,41],{"lat":41,"lon":40},{"facility":59,"status":34,"city":60,"state":20,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"AIG Hospitals (Asian Institute of Gastroenterology)","Hyderabad","500032","India","IN",{"type":38,"coordinates":65},[66,67],78.45636,17.38405,{"lat":67,"lon":66},[70,74],{"name":71,"role":24,"phone":72,"phoneExt":20,"email":73},"Sundeep Lakhtakia, MD","+919848040629","drsundeeplakhtakia@gmail.com",{"name":75,"role":24,"phone":76,"phoneExt":20,"email":77},"Sana Fatima, MSc","+918297918513","sana.aigindia@gmail.com",{"facility":79,"status":34,"city":80,"state":20,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Sunway Medical Centre","Kuala Lumpur","47500","Malaysia","MY",{"type":38,"coordinates":85},[86,87],101.68653,3.1412,{"lat":87,"lon":86},[90,92],{"name":23,"role":24,"phone":91,"phoneExt":20,"email":26},"0374919191",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"facility":94,"status":95,"city":80,"state":20,"zip":96,"country":82,"countryCode":83,"cosmosGeoPoint":97,"geoPoint":99,"contacts":20},"Universityi Kebangsaan Malaysia (UKM)","COMPLETED","56000",{"type":38,"coordinates":98},[86,87],{"lat":87,"lon":86},{"facility":101,"status":34,"city":80,"state":20,"zip":102,"country":82,"countryCode":83,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC)","59100",{"type":38,"coordinates":104},[86,87],{"lat":87,"lon":86},[107,111],{"name":108,"role":24,"phone":109,"phoneExt":20,"email":110},"Shiaw-Hooi Ho, MD","+603-7954-1904","shooiho@yahoo.com",{"name":112,"role":24,"phone":113,"phoneExt":20,"email":114},"Lorraine Angal, MSc","+60198609606","lorainne@um.edu.my",{"type":116,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100433876","unity-b-a-prospective-multicentric-single-arm-study-to-evaluate-the-safety-and-efficacy-of-the-unity-b-biodegradable-balloon-expandable-biliary-stent-system-in-subjects-with-biliary-strictures-100433876",false,"NCT04929821","UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures","Inclusion Criteria:\n\n* 1\\) A subject with a biliary stricture may be entered into the study with: at least one of the following:\n* Benign fibrotic distal bile duct obstruction\n* Duct occlusion caused by cholelithiasis\n* A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and\u002For ERCP with proximal ductal dilation and cholestatic liver enzymes levels\n* Ductal anastomotic strictures\n* Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla.\n* Neoplasm diagnosed on clinical and imaging findings\n* Post-ERCP pancreatitis\n* Obstructive jaundice with evidence of pruritus, tea color urine and pale stool\n* Abnormal Bilirubin rate or\n* A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or\n* A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old\n\nExclusion Criteria:\n\nPatients, male or female, presenting with the following criteria may be included:\n\n1. Subject is unwilling to comply with the follow-up schedule\n2. Life expectancy \\\u003C 12 m,\n3. Inability to pass a guidewire through stricture\n4. Contra-indication for endoscopy or interventional radiology\n5. History of allergic reactions to one of the compounds of investigational product.\n6. Subject is unable or refuses to give informed consent\n7. Subject is pregnant or breastfeeding\n8. Patient under tutorship\n9. Currently participating in another trial before reaching first endpoint.\n10. Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma\n11. Patient need additional biliary stenting with another device than the study device.\n\n    \\-","ALL","18 Years",{"count":126,"type":127},100,"ESTIMATED","INTERVENTIONAL",[130],"NA","STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY OBJECTIVES Clinical \u002FTechnical \u002FProcedural success, Quality of Life improvement, biodegradation rate",[133,134,135],"Biliary Obstruction","Bile Duct Stricture","Bile Duct Diseases","2026-06-16",{"date":138,"type":139},"2026-06-17","ACTUAL",{"date":141,"type":139},"2017-10-16",{"date":143,"type":127},"2026-07",{"name":5,"class":6},6]