[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353828":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":48,"collaborators":50,"id":54,"slug":31,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":17,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":31,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":31,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lung Transplant Patients","EXPERIMENTAL","For the first four weeks, lung transplant patients will not wear the Reflux Band. Use of the Reflux Band will subsequently commence in the next four weeks.",[13],"Device: Reflux Band",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Reflux Band","The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.",[9],[21],"Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device",[23],{"name":24,"affiliation":5,"role":25},"Manuel Amaris, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Vanessa Scheuble","CONTACT","352-273-7589",null,"Vanessa.Scheuble@medicine.ufl.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":31},"UF Health at the University of Florida","RECRUITING","Gainesville","Florida","32610","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-82.32483,29.65163,{"lat":46,"lon":45},{"type":49,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[51],{"name":52,"class":53},"Somna Therapeutics, L.L.C.","INDUSTRY","100353828",false,"NCT03886961","The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients","Inclusion Criteria:\n\n* Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits\n* 13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation\n* Patient must be willing and able to provide informed consent\n* Understands the clinical study requirements and is able to comply with follow-up schedule\n\nExclusion Criteria:\n\n* Currently being treated with another investigational medical device and\u002For drug\n* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)\n* Previous head or neck surgery \u002F radiation\n* Carotid artery disease, thyroid disease, or history of cerebral vascular disease\n* Nasopharyngeal cancer\n* Suspected esophageal cancer","ALL","18 Years","80 Years",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"NA","A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.",[70,71],"Lung Transplant","GERD","2025-07-15",{"date":74,"type":75},"2025-07-16","ACTUAL",{"date":77,"type":75},"2019-05-17",{"date":79,"type":64},"2027-12-20",{"name":5,"class":6},1]