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

Description

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.

Conditions

Lung Transplant, GERD

Talk to us

Study Overview

On this page

Study Details

Study 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.

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

Condition
Lung Transplant
Intervention / Treatment

-

Contacts and Locations

Gainesville

UF Health at the University of Florida, Gainesville, Florida, United States, 32610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Manuel Amaris, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2025-03-20