[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endoscopic-fundoplication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endoscopic-fundoplication":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":5},"100337163",false,"NCT03669874","Endoscopic Fundoplication With MUSE System","Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients","Inclusion Criteria:\n\n* Chronic (\\> 6 months) GERD-related esophageal or extra-esophageal symptoms\n* Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)\n* Indication to surgical fundoplication\n* Patients available for a long-term follow-up\n\nExclusion Criteria:\n\n* Hiatal hernia ≥ 3 cm\n* Major esophageal motility disorder\n* Esophageal stenosis\n* Malignant neoplasia (except minor superficial skin neoplasm)\n* Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula\n* Previous cardiac, thoracic or upper GI surgery\n* BMI \\>40\n* Pregnancy or breast feeding","ALL","18 Years","70 Years",{"count":19,"type":20},80,"ESTIMATED","OBSERVATIONAL","This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:\n\n* Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:\n\n  * effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores\n  * effect on the use and dosage of proton pump inhibitors (PPI)\n  * feasibility and safety of the endoluminal fundoplication procedure\n* Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.\n\nThe study design includes the following phases:\n\n\\*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI\n\n* 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI\n* 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI\n* Yearly clinical follow-up (up to 6 years):\n\nPPI use GERD-HRQL and RSI questionnaires scores OFF PPI",[24,25],"Gastro-esophageal Reflux","Endoscopic Fundoplication","RECRUITING","2020-12-10",{"date":29,"type":30},"2020-12-11","ACTUAL",{"date":32,"type":30},"2015-09-16",{"date":34,"type":20},"2026-09",{"name":36,"class":37},"IRCCS San Raffaele","OTHER",""]