[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416869":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":22,"armGroups":23,"interventions":29,"overallOfficials":18,"centralContacts":35,"locations":45,"responsibleParty":195,"collaborators":18,"id":197,"slug":198,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":18,"enrollmentInfo":207,"targetDuration":18,"studyType":210,"phases":18,"briefSummary":211,"conditions":212,"keywords":18,"overallStatus":73,"whyStopped":18,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"QualiMed Innovative Medizinprodukte GmbH","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Safety endpoint","Proportion of subjects experiencing procedure- or device-related complications within 30 days including Post-ERCP pancreatitis, Bleeding, Perforation (biliary\u002Fpancreatic\u002Fduodenal), Stent misplacement, Stent migration, Biliary occlusion, Cholangitis, Severe pain, All-cause death Within 30 days of the index procedure","From enrollment to the end of treatment, as per the standard of care.",[14],{"measure":15,"description":16,"timeFrame":17},"Secondary endpoints are defined as:","Clinical success: patency rate as defined by the rate of freedom of stent replacements at follow-up time points defined by investigators definition of SOC (standard of care) or until planned bridge surgery (defined as no need of stent replacement).\n\nTechnical success: Accurate stent deployment across the target stricture as evaluated by fluoroscopy and endoscopy.\n\nProcedural success will be quantified (using a dedicated score system, Excellence=1, Good=2, Fair=3, Poor=4) by the endoscopist post procedure using the following components:\n\n* Stent loadability\n* Trackability over Guide Wire\n* Pushibility with push catheter\n* Visualization by fluoroscopy\n* Stent repositiong when required\n* Deployment accuracy","Technical and Procedural success on the Procedure day and clinical success as per the Standard of Care",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","Patients that will respect the inlcusion criteria will be enrolled in the study.",[24],{"label":25,"type":18,"description":26,"interventionNames":27},"Patients will treated with ARCHIMEDES Biodegradable Biliary and Pancreatic Stent in routine practice","Participants receiving commercially available ARCHIMEDES Biodegradable Biliary and Pancreatic as part of standard care. Safety outcomes are collected for post-marketing surveillance",[28],"Device: ARCHIMEDES Biodegradable Biliary and Pancreatic Stent",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":18},"DEVICE","ARCHIMEDES Biodegradable Biliary and Pancreatic Stent","Patients will treated with ARCHIMEDES Biodegradable Biliary and Pancreatic Stent in routine clinical practice",[25],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":18,"email":40},"NIta Gondaliya","CONTACT","+49 1716578285","ngondaliya@q3medical.com",{"name":42,"role":38,"phone":43,"phoneExt":18,"email":44},"Manfred Guelcher","+4941716578200","mguelcher@q3medical.com",[46,59,71,94,105,117,126,135,144,154,176],{"facility":47,"status":48,"city":49,"state":18,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":18},"HUS Helsinki University Hospital","COMPLETED","Helsinki","00290","Finland","FI",{"type":54,"coordinates":55},"Point",[56,57],24.93545,60.16952,{"lat":57,"lon":56},{"facility":60,"status":61,"city":62,"state":18,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":18},"Hôpital Européen Georges-Pompidou HEGP Service d'Hépato-gastro-entérologie et endoscopies digestives","ACTIVE_NOT_RECRUITING","Paris","75015","France","FR",{"type":54,"coordinates":67},[68,69],2.3488,48.85341,{"lat":69,"lon":68},{"facility":72,"status":73,"city":74,"state":18,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Evangelisches Krankenhaus Düsseldorf","RECRUITING","Düsseldorf","40217","Germany","DE",{"type":54,"coordinates":79},[80,81],6.77927,51.22319,{"lat":81,"lon":80},[84,88,91],{"name":85,"role":38,"phone":86,"phoneExt":18,"email":87},"Biljana Dimitrijevic, PhD","+49 (0)211919483 601","Biljana.Dimitrijevic@evk-duesseldorf.de",{"name":89,"role":38,"phone":18,"phoneExt":18,"email":90},"Carina Friesl","carina.friesl@evk-duesseldorf.de",{"name":92,"role":93,"phone":18,"phoneExt":18,"email":18},"Dr. Thomas Veiser, PhD","PRINCIPAL_INVESTIGATOR",{"facility":95,"status":48,"city":96,"state":18,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":18},"Emek Medical Center","Afula","1834111","Israel","IL",{"type":54,"coordinates":101},[102,103],35.2892,32.60907,{"lat":103,"lon":102},{"facility":106,"status":61,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":116,"contacts":18},"Endoscopy Unit, Humanitas Research Hospital","Rozzano","Milano","20089","Italy","IT",{"type":54,"coordinates":113},[114,115],9.1559,45.38193,{"lat":115,"lon":114},{"facility":118,"status":48,"city":119,"state":18,"zip":120,"country":110,"countryCode":111,"cosmosGeoPoint":121,"geoPoint":125,"contacts":18},"AUSL Romagna Ospedale Morgagni - Pierantoni","Forlì","47121",{"type":54,"coordinates":122},[123,124],12.04144,44.22177,{"lat":124,"lon":123},{"facility":127,"status":61,"city":128,"state":18,"zip":129,"country":110,"countryCode":111,"cosmosGeoPoint":130,"geoPoint":134,"contacts":18},"Gastroenterology and Digestive Endoscopy Unit Fondazione I.R.C.C.S. Policlinico San Matteo","Pavia","27100",{"type":54,"coordinates":131},[132,133],9.15917,45.19205,{"lat":133,"lon":132},{"facility":136,"status":61,"city":137,"state":18,"zip":138,"country":110,"countryCode":111,"cosmosGeoPoint":139,"geoPoint":143,"contacts":18},"UCBM - Campus Bio-Medico University","Roma","00128",{"type":54,"coordinates":140},[141,142],11.10642,44.99364,{"lat":142,"lon":141},{"facility":145,"status":48,"city":146,"state":18,"zip":147,"country":146,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":18},"Tan Tock Seng Hospital Pte Ltd,","Singapore","308433","SG",{"type":54,"coordinates":150},[151,152],103.85007,1.28967,{"lat":152,"lon":151},{"facility":155,"status":73,"city":156,"state":18,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"University Medical Center Ljubljana","Ljubljana","1000","Slovenia","SI",{"type":54,"coordinates":161},[162,163],14.50513,46.05108,{"lat":163,"lon":162},[166,170,174],{"name":167,"role":38,"phone":168,"phoneExt":18,"email":169},"Karin Pulevic, VS","+38615228515","karin.pulevic@kclj.si",{"name":171,"role":38,"phone":172,"phoneExt":18,"email":173},"Dr. Martina Jaklič, MD","+38615222037","martina.jaklic@kclj.si",{"name":175,"role":93,"phone":18,"phoneExt":18,"email":18},"Dr Samo Plut, MD",{"facility":177,"status":73,"city":178,"state":18,"zip":179,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Hospital Universitario de Salamanca","Salamanca","37007","Spain","ES",{"type":54,"coordinates":183},[184,185],-5.66388,40.96882,{"lat":185,"lon":184},[188,193],{"name":189,"role":38,"phone":190,"phoneExt":191,"email":192},"Solorzano Garcia Ignacio","+34 679441022","55400","isolorzano.ibsal@saludcastillayleon.es",{"name":194,"role":93,"phone":18,"phoneExt":18,"email":18},"Dr. Alberto Álvarez Delgado, MD, PhD",{"type":196,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":208,"type":209},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.",[213],"Obstructed Biliary and Pancreatic Duct","2026-10-01",{"date":216,"type":217},"2026-10-05","ACTUAL",{"date":219,"type":217},"2020-10-03",{"date":221,"type":209},"2027-12-31",{"name":5,"class":6},11]