RecruitingNot ApplicableNCT03886961
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Sponsor
University of Florida
Enrollment
20 participants
Start Date
May 17, 2019
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits
- 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 Criteria6
- 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
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Interventions
DEVICEReflux Band
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03886961
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