The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients

The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients

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.

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