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



Status:Not yet recruiting
Conditions:Gastroesophageal Reflux Disease , Hospital
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:18 - 80
Updated:3/24/2019
Start Date:April 2019
End Date:May 2020
Contact:Vanessa Scheuble
Email:Vanessa.Scheuble@medicine.ufl.edu
Phone:352-273-7589

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Trial Summary
Trial Overview
Inclusion Criteria
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 pressure
(CPAP)

- Previous head or neck surgery / radiation

- Carotid artery disease, thyroid disease, or history of cerebral vascular disease

- Nasopharyngeal cancer

- Suspected esophageal cancer
We found this trial at
1
site
UF Health at the University of Florida
2033 Mowry Road
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
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