[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444374":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":57,"collaborators":10,"id":60,"slug":10,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":73,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)",null,"Patients treated by transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions) for gastro-esophageal reflux disease will be enrolled in the registry and clinically followed-up for 5 years from the date of TIF procedure.",[13],"Device: Transoral incisionless fundoplication",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Transoral incisionless fundoplication","The intervention of transoral incisionless fundoplication using the EsophyX (EndoGastric Solutions) system allows, through the endoscopic route, the creation of a cardial neovalve of approximately 270 ° by placing 20-28 polyethylene sutures on the cardial circumference, resulting in an anti-reflux plastic functionally similar to that obtained with the surgical fundoplication.",[9],[21],{"name":22,"affiliation":5,"role":23},"Pier Alberto Testoni, Prof.","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Pier Alberto Testoni, MD, Prof.","CONTACT","+39 02\u002F26432756","testoni.pieralberto@hsr.it",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Sabrina Gloria Giulia Testoni, MD, PhD","+39 02\u002F26436303","testoni.sabrinagloriagiulia@hsr.it",[35],{"facility":5,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Milan","20132","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.18951,45.46427,{"lat":45,"lon":44},[48,49,50,51,53,55],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},{"name":26,"role":23,"phone":10,"phoneExt":10,"email":10},{"name":31,"role":52,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":54,"role":52,"phone":10,"phoneExt":10,"email":10},"Sandro Passaretti, MD",{"name":56,"role":52,"phone":10,"phoneExt":10,"email":10},"Emanuela Ribichini, MD, PhD",{"type":23,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Pier Alberto Testoni","Head of Gastroenterology and Digestive Endoscopy","100444374",false,"NCT05066594","Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)","Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease","TIF\u002F2021","Inclusion Criteria for enrollment:\n\n* Clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;\n* Availability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;\n* Signed informed consent for participation in the observational registry.\n\nExclusion Criteria for enrollment:\n\n* Absence of clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;\n* Unavailability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;\n* No signed informed consent for participation in the observational registry.","ALL","18 Years","80 Years",{"count":71,"type":72},100,"ESTIMATED","5 Years","OBSERVATIONAL","This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.",[77],"Gastro Esophageal Reflux",[79,80,77],"Fundoplication","Endoscopy, Digestive System","2021-09-24",{"date":83,"type":84},"2021-10-04","ACTUAL",{"date":86,"type":84},"2021-05-01",{"date":88,"type":72},"2029-05",{"name":5,"class":6},1]