Overview
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
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