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Reflux Band for Lung Transplant Patients with GERD

This study is testing a device called the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device. It's for lung transplant patients who also have GERD (Gastroesophageal Reflux Disease), a condition where stomach acid flows back into the esophagus. The study wants to see if wearing the Reflux Band while sleeping for four weeks can help reduce reflux. Researchers will measure levels of pepsin and amylase (substances found in reflux) to see if the device is effective. You might be able to join if you are a stable lung transplant patient between 18 and 80 years old, and have documented gastric reflux.

Study design
This is an open-label study, meaning both you and the researchers will know you are using the Reflux Band. It plans to enroll 20 participants.
What's involved
You would wear the Reflux Band while sleeping for 4 weeks, starting 8 weeks after your transplant. Pepsin and amylase levels will be measured at the beginning, at week 4, and at week 8.
Compensation
Not stated in the trial record.
Follow-up
Your pepsin and amylase levels will be measured up to 8 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03886961

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

Recruiting
NAAges 18–80InterventionalPrevention
University of Florida
~20 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Reflux Band

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pepsin levels
Measured over Baseline; Week 4; Week 8
+1 more outcome measured

Conditions

Lung Transplant
GERD

Explore related trials

Gastroesophageal Reflux DiseaseLung Transplantation

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Manuel Amaris, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Vanessa Scheuble
[email protected]
352-273-7589
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in pepsin levelsBaseline; Week 4; Week 8

    The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.

  • Change in amylase levelsBaseline; Week 4; Week 8

    The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.