[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544105":3},{"organization":4,"armGroups":7,"interventions":12,"overallOfficials":17,"centralContacts":18,"locations":24,"responsibleParty":43,"collaborators":17,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":17,"enrollmentInfo":56,"targetDuration":17,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":17,"overallStatus":27,"whyStopped":17,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8],{"label":9,"type":6,"description":9,"interventionNames":10},"Esophageal self-expandable metal stent",[11],"Device: Esophageal self-expandable metal stent",[13],{"type":14,"name":9,"description":15,"armGroupLabels":16,"otherNames":17},"DEVICE","The Leufen Esophageal aixstent ® (Leufen Medical GmbH) is indicated for the treatment of malignant esophageal strictures and postoperative stenosis. It is comprised of two components: an implantable metallic stent and the delivery system. After the procedure, the stent remains at the intended location, within the patient while the delivery system is removed.",[9],null,[19],{"name":20,"role":21,"phone":22,"phoneExt":17,"email":23},"Annemijn D I Maan","CONTACT","+31653305615","a.maan@erasmusmc.nl",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Erasmus MC","RECRUITING","Rotterdam","South Holland","3015GD","Netherlands","NL",{"type":34,"coordinates":35},"Point",[36,37],4.47917,51.9225,{"lat":37,"lon":36},[40],{"name":41,"role":21,"phone":42,"phoneExt":17,"email":23},"Annemijn Maan, MD","+31650033984",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Peter Siersema","Prof. dr.","100544105","esophageal-self-expandable-metal-stent-for-malignant-strictures-a-safety-and-efficacy-study-100544105",false,"NCT06364553","Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study","ENTRANCE","Inclusion Criteria:\n\n* Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;\n* Requiring treatment for dysphagia (Ogilvie score of 2-41);\n* Life expectancy of less than 12 months;\n* Written informed consent;\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* Stenosis after laryngectomy;\n* Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;\n* Tumor length of more than 14 cm;\n* Previous stent placement for the same condition;\n* Coagulopathy (not corrected prior to stent placement);\n* Patients with eosinophilic esophagitis or an esophageal motility disorder;\n* Nickel titanium (Nitinol) allergy.","ALL","18 Years",{"count":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"NA","A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.",[64],"Oesophageal Cancer","2025-08-04",{"date":67,"type":68},"2025-08-07","ACTUAL",{"date":70,"type":68},"2024-10-02",{"date":72,"type":58},"2025-10-01",{"name":5,"class":6},1]