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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

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Conditions

Lung TransplantGERD

Locations

UF Health at the University of Florida

Gainesville, Florida 32610

United States