Using a device to reduce reflux in lung transplant patients
Official title: The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Run by University of Florida · NCT03886961 · Data updated 2026-11-12
This study is testing whether the Reflux Band™ device can help lung transplant patients manage their acid reflux symptoms better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | May 17, 2019 |
| Main results expected | March 20, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT03886961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are clinically stable lung transplant patients who have experienced abnormal reflux symptoms.
✕Probably not a fit
Patients currently undergoing treatment for sleep apnea or those with a history of certain cancers or vascular diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the Reflux Band™ Upper Esophageal Sphincter Assist Device in managing gastroesophageal reflux disease (GERD) in patients who have undergone lung transplantation. It is a prospective, open-label intervention aimed at assessing reflux symptoms and esophageal function in this specific patient population. Participants will be monitored for their ability to tolerate the device and its impact on their reflux symptoms over time.
Why it matters
Potential benefit: If successful, this device could significantly improve the quality of life for lung transplant recipients suffering from reflux.
How similar studies have gone: While the use of devices for reflux management is established, this specific application in lung transplant recipients is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UF Health at the University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Manuel Amaris, MD — University of Florida
- Study coordinator: Vanessa Scheuble
- Email: Vanessa.Scheuble@medicine.ufl.edu
- Phone: 352-273-7589
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Research on improving outcomes for lung transplant donors and recipients
This study is trying to see how different donor and medical practices affect the health of lung transplant patients and donors, while also looking for blood markers that might predict complications after the surgery.
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Thread-Embedding Acupuncture plus a Proton Pump Inhibitor for GERD
This study tests whether adding thread-embedding acupuncture to standard omeprazole treatment helps people with GERD who have a traditional Liver-Stomach constraint-heat pattern.
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Transoral incisionless fundoplication (TIF) for GERD in Asian adults
This tests whether a less-invasive transoral incisionless fundoplication (TIF) procedure can reduce reflux symptoms in Asian adults who continue to have GERD despite daily PPI treatment.
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Diaphragm training for GERD symptoms
This study will test whether diaphragm-focused breathing exercises or using a volume-based incentive spirometer can help people with GERD have fewer reflux episodes and better symptoms.
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Multimodal prospective approach to understand acute and chronic lung transplant rejection
This project will see if blood tests, airway sampling, imaging, and genetic analyses can identify which adults who have had or are being evaluated for a lung transplant will develop antibody‑mediated rejection and later chronic graft dysfunction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.