Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-09 @ 11:01 AM
Study NCT ID:
NCT03886961
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2019-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pepsin levels', 'timeFrame': 'Baseline; Week 4; Week 8', 'description': 'The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.'}, {'measure': 'Change in amylase levels', 'timeFrame': 'Baseline; Week 4; Week 8', 'description': 'The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung Transplant', 'GERD']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or drug\n* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)\n* Previous head or neck surgery / radiation\n* Carotid artery disease, thyroid disease, or history of cerebral vascular disease\n* Nasopharyngeal cancer\n* Suspected esophageal cancer'}, 'identificationModule': {'nctId': 'NCT03886961', 'acronym': 'Reflux Band', 'briefTitle': 'The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients', 'orgStudyIdInfo': {'id': 'IRB201900469 -A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung Transplant Patients', 'description': '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.', 'interventionNames': ['Device: Reflux Band']}], 'interventions': [{'name': 'Reflux Band', 'type': 'DEVICE', 'otherNames': ['Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device'], 'description': 'The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.', 'armGroupLabels': ['Lung Transplant Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UF Health at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'centralContacts': [{'name': 'Vanessa Scheuble', 'role': 'CONTACT', 'email': 'Vanessa.Scheuble@medicine.ufl.edu', 'phone': '352-273-7589'}], 'overallOfficials': [{'name': 'Manuel Amaris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Somna Therapeutics, L.L.C.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}