Using a device to reduce reflux in lung transplant patients
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
This study is testing whether the Reflux Band™ device can help lung transplant patients manage their acid reflux symptoms better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT03886961 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are clinically stable lung transplant patients who have experienced abnormal reflux symptoms.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.