[{"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":17,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":17,"enrollmentInfo":55,"targetDuration":17,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":17,"overallStatus":27,"whyStopped":17,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"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",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":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60],"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.",[63],"Oesophageal Cancer","2025-08-04",{"date":66,"type":67},"2025-08-07","ACTUAL",{"date":69,"type":67},"2024-10-02",{"date":71,"type":57},"2025-10-01",{"name":5,"class":6},1]