University of Florida
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…
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
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