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

Launched by UNIVERSITY OF FLORIDA · Mar 21, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of a device called the Reflux Band™ to help lung transplant recipients who experience reflux, a condition where stomach contents flow back into the esophagus. The goal is to see if this device can improve their reflux symptoms. The study is currently looking for participants aged 65 to 74 who are clinically stable after their lung transplant and have shown signs of reflux before their transplant.

To be eligible for this trial, participants must be stable in their lung function and willing to follow the study's requirements. However, those who are using other medical devices, receiving treatment for sleep apnea, or have certain health conditions like recent neck surgery or specific cancers cannot participate. If you join the study, you will be monitored closely to see how the Reflux Band affects your symptoms over time. This trial aims to find better solutions for managing reflux in lung transplant patients.

Gender

ALL

Eligibility criteria

• 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