NCT03886961NARecruiting
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
University of Florida
Start Date
5/17/2019
Completion Date
12/20/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to 80 years
Inclusion Criteria:
* 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
Exclusion Criteria:
* Currently being treated with another investigational medical device and/or drug
* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
* Previous head or neck surgery / radiation
* Carotid artery disease, thyroid disease, or history of cerebral vascular disease
* Nasopharyngeal cancer
* Suspected esophageal cancer
Interventions
DEVICE
Reflux Band
Conditions
Lung TransplantGERD
Locations
UF Health at the University of Florida
Gainesville, Florida 32610
United States