[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03886961":3,"trial-entities:NCT03886961":88,"trial-summary:NCT03886961":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":63,"locations":66,"central_contacts":76,"overall_officials":82,"references":86,"see_also_links":87},"NCT03886961","IRB201900469 -A","The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients","RECRUITING","2027-12-20","2026-07","2026-07-13","2019-05-17","University of Florida","OTHER",null,"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.",[17,18],"Lung Transplant","GERD",[],"INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},20,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DEVICE","Reflux Band","The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.",[33],"Lung Transplant Patients",[35],"Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device",[37,41],{"measure":38,"description":39,"timeFrame":40},"Change in pepsin levels","The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.","Baseline; Week 4; Week 8",{"measure":42,"description":43,"timeFrame":40},"Change in amylase levels","The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.",[],"ALL","18 Years","80 Years",false,{"inclusion":50,"exclusion":55,"raw_text":62},[51,52,53,54],"Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits","13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation","Patient must be willing and able to provide informed consent","Understands the clinical study requirements and is able to comply with follow-up schedule",[56,57,58,59,60,61],"Currently being treated with another investigational medical device and\u002For drug","Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)","Previous head or neck surgery \u002F radiation","Carotid artery disease, thyroid disease, or history of cerebral vascular disease","Nasopharyngeal cancer","Suspected esophageal cancer","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",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"status":7,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"UF Health at the University of Florida","Gainesville","Florida","32610","United States",{"lat":74,"lon":75},29.65163,-82.32483,[77],{"name":78,"role":79,"phone":80,"email":81},"Vanessa Scheuble","CONTACT","352-273-7589","Vanessa.Scheuble@medicine.ufl.edu",[83],{"name":84,"affiliation":12,"role":85},"Manuel Amaris, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":92},[90,91],"Gastroesophageal Reflux Disease","Lung Transplantation",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an open-label study, meaning both you and the researchers will know you are using the Reflux Band. It plans to enroll 20 participants.","completed","Reflux Band for Lung Transplant Patients with GERD","This study is testing a device called the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device. It's for lung transplant patients who also have GERD (Gastroesophageal Reflux Disease), a condition where stomach acid flows back into the esophagus. The study wants to see if wearing the Reflux Band while sleeping for four weeks can help reduce reflux. Researchers will measure levels of pepsin and amylase (substances found in reflux) to see if the device is effective. You might be able to join if you are a stable lung transplant patient between 18 and 80 years old, and have documented gastric reflux.","Your pepsin and amylase levels will be measured up to 8 weeks after starting the study.",101,"You would wear the Reflux Band while sleeping for 4 weeks, starting 8 weeks after your transplant. Pepsin and amylase levels will be measured at the beginning, at week 4, and at week 8.","Not stated in the trial record.",[30],"v2"]