[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"QualiMed Innovative Medizinprodukte GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100416869","to-evaluate-the-safety-and-clinical-performance-of-the-archimedes-biodegradable-biliary-and-pancreatic-stent-100416869",false,"NCT04708288","To Evaluate the Safety and Clinical Performance of the ARCHIMEDES Biodegradable Biliary and Pancreatic Stent","A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM, POST MARKET OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND CLINICAL PERFORMANCE OF THE ARCHIMEDES BIODEGRADABLE BILIARY AND PANCREATIC STENT","Registry","Inclusion Criteria:\n\n* Patient eligible for implantation of a pancreatic or billiary stent prior to participate in the study and according to current guidelines\n* Patient has provided a signed and dated informed consent (according to the laws and regualtions of the country in which the observational study is conducted)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 y\n* Inability to understand the purpose of the study or refusal to cooperate\n* Not available for routine follow-up visits\n* Pregnancy\n* Currently participating in a confounding trial before reaching first endpoint.","ALL","18 Years",{"count":20,"type":21},198,"ESTIMATED","OBSERVATIONAL","Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium. Stents are typically made from polymeric materials including Polylactic Acid (PLA), Polyglycolide (PGA), Polydioxanone (PDO), Polyethyleneglycol (PEG), Polycaprolactone (PCL), etc., which have been cleared or approved by the FDA and CE-marked as drug carriers, sutures, and bone fixatives. The material is degraded by hydrolysis in, e.g., lactic acid, which is removed from the body by normal metabolic pathways. In the field of gastroenterology, these stents were first introduced in patients with an esophageal stenosis with encouraging results, although esophageal hyperplasia was a frequently encountered complication.\n\nFor biliary applications, biodegradable stents have been evaluated in several in-vitro and animal studies that demonstrated that the stents were safe and well tolerated. These stents provided an adequate radial force and resulted in complete stricture resolution within several months. The stents did not show any signs of biliary hyperplasia or integration in the epithelium. Moreover, they seem to have a self-clearing effect on attached biofilm as the outer layer sloughs during the degradation process similarly to the exfoliation of human skin. Also, the stent could be removed from the bile duct, thus offering the possibility of extraction if necessary at various times after implantation.\n\nIn 2010, Petryl was the first to use a biodegradable stent in the human bile duct. A stent was successfully placed using percutaneous transhepatic cholangiograpy in two patients with a postsurgical intrahepatic biliary stricture. Transient cholangitis was the only complication encountered and during the two years of follow-up, the bile duct remained patent.\n\nLater, Mauri et al. presented in 2013 and 2016 results of a 107 patient study on a polydioxanone biodegradable biliary stent. The results have been published in the Journal of the European Society of Radiology. The authors concluded that percutaneous placement of a biodegradable biliary stent is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period.\n\nPrior to this study, the ARCHIMEDES device was assessed in the ARCHIMEDES Investigational study which has completed enrolment with 53 patients included, and the results are not yet published. In this study approximately half the stents were deployed in the bile duct (53%) and half in the pancreatic duct. All 53 patients have either completed, exited, or no longer have the study device. No patient remains in the study with a stent in place during the time of the last patient follow-ups. The study concluded without any device-related SAE. Bilirubin was reduced by 25.6%, which exceeded the \\>20% clinical success criterion, quality of life score improved from 3.7 to 7.9, procedural success was rated 1.4 (good to excellent), and technical success was achieved in all 53 patients.\n\nData from the ARCHIMEDES Investigational study was used for CE Mark approval, which was obtained in June 2018.",[25],"Obstructed Biliary and Pancreatic Duct","RECRUITING","2026-06-25",{"date":29,"type":30},"2026-06-30","ACTUAL",{"date":32,"type":30},"2020-10-03",{"date":34,"type":21},"2027-12-31",{"name":36,"class":37},"QualiMed Innovative Medizinprodukte GmbH","INDUSTRY",11,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"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","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    \\-",{"count":46,"type":21},100,"INTERVENTIONAL",[49],"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",[52,53,54],"Biliary Obstruction","Bile Duct Stricture","Bile Duct Diseases","2026-06-16",{"date":57,"type":30},"2026-06-17",{"date":59,"type":30},"2017-10-16",{"date":61,"type":21},"2026-07",{"name":36,"class":37},6,""]