[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568024":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":34,"locations":35,"responsibleParty":90,"collaborators":34,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":34,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":38,"whyStopped":34,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University Children's Hospital, Zurich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group 1: BougieCap","EXPERIMENTAL","Patients randomized into this group will undergo the dilation using the BougieCap.",[13],"Device: BougieCap",{"label":15,"type":16,"description":17,"interventionNames":18},"Study Group 2: Standard treatment","ACTIVE_COMPARATOR","Patients randomized to the standard treatment arm will be provided one of the two standard dilation techniques, Savary- Bougie dilation or balloon dilation. This procedure could take place under endoscopic or radiological control.",[19],"Device: Savary-Bougie (A) or balloon dilation (B)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","BougieCap","The BougieCap is attached to the tip of the endoscope, offers direct visual and tactile control and the endoscope acts as a carrier of the radial and longitudinal force vectors for the dilation.",[9],[27],"Esophageal dilation",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Savary-Bougie (A) or balloon dilation (B)","A: In the Savary- Bougie treatment, dilators of different sizes are advanced to dilate the stenosis. The same procedure is then repeated with the next larger dilator, with the position of the dilator being checked radiologically each time.\n\nB: In the case of balloon dilation, a balloon is inserted and inflated at the level of the stenosis. Depending on the age of the child and possibly also the etiology of the stenosis, different balloons sizes are applied, which are then maintained inflated for about one until three minutes and the respective pressure. This procedure could take place under endoscopic or radiological control.",[15],[33,27],"Dilation of esophageal stricture",null,[36,56,75],{"facility":37,"status":38,"city":39,"state":34,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome,","RECRUITING","Rome","00161","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],12.51133,41.89193,{"lat":47,"lon":46},[50,55],{"name":51,"role":52,"phone":53,"phoneExt":34,"email":54},"Salvatore Oliva, Prof. Dr. med.","CONTACT","+39(0)649979330","salvatore.oliva@uniroma1.it",{"name":51,"role":52,"phone":34,"phoneExt":34,"email":34},{"facility":57,"status":38,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"University Children's Hospital Zurich","Zurich","Canton of Zurich","8032","Switzerland","CH",{"type":44,"coordinates":64},[65,66],8.55,47.36667,{"lat":66,"lon":65},[69,73],{"name":70,"role":52,"phone":71,"phoneExt":34,"email":72},"Carsten Posovszky","+41 44 266 34 54","carsten.posovszky@kispi.uzh.ch",{"name":74,"role":52,"phone":34,"phoneExt":34,"email":34},"Vasiliki Spyropoulou, Dr. med.",{"facility":76,"status":38,"city":77,"state":34,"zip":78,"country":61,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Universitäts-Kinderspital beider Basel","Basel","4056",{"type":44,"coordinates":80},[81,82],7.57327,47.55839,{"lat":82,"lon":81},[85,89],{"name":86,"role":52,"phone":87,"phoneExt":34,"email":88},"Raoul I. Furlano, Prof. Dr. med.","+41 61 704 29 05","raoul.furlano@ukbb.ch",{"name":86,"role":52,"phone":34,"phoneExt":34,"email":34},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Vasiliki Spyropoulou","Principal Investigator","100568024","an-innovative-endoscopic-cap-for-dilating-benign-esophageal-strictures-in-children-100568024",false,"NCT06675825","An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children","A Novel Endoscopic Attachment Cap for Benign Esophageal Stricture Dilation in Children: a Randomized, Multicentric Pilot Study.","BOUGIE-PED","Inclusion Criteria:\n\n* Age under 18 years of age\n* Indication for endoscopic esophageal dilation\n* Benign stenosis\n* Written Informed Consent signed by the subject and\u002For parent\u002Flegal representative (if applicable)\n\nExclusion Criteria:\n\n* Stenosis that cannot be treated endoscopically\n* Malignant esophageal strictures\n* Contraindications and limitations of the MD as described in the instructions for use","ALL","0 Years","18 Years",{"count":106,"type":107},40,"ESTIMATED","INTERVENTIONAL",[110],"NA","The goal of this study is to find out if using the BougieCap device is a safe and effective way to stretch narrow areas in the esophagus (food pipe) in children. The main questions this study wants to answer are:\n\n* Does the BougieCap work well to treat narrow areas in the esophagus comparing with other methods to widen these narrow areas?\n* Is BougieCap easy to use and does it cause fewer problems or discomfort for children?\n\nResearchers will compare two groups: one using the BougieCap, and the other using traditional methods like balloon dilation, to see which one works better and is safer.\n\nParticipants will:\n\n* Answer questions about their symptoms before treatment, 24 hours after, and 14 days later.\n* Complete these questions during regular hospital visits or over the phone for the final check-up.\n\nThis study does not involve any extra risks or burdens for the participants.",[113,114],"Esophageal Stenosis","Esophageal Dilation",[116,117,118],"esophageal stricture","esophageal dilation","pediatric gastroenterology","2024-12-10",{"date":121,"type":122},"2024-12-11","ACTUAL",{"date":124,"type":107},"2025-01",{"date":126,"type":107},"2026-12",{"name":5,"class":6},3]