NCT03886961 The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
| NCT ID | NCT03886961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Lung Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-05-17 |
| Primary Completion | 2027-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2019-05-17 with a primary completion date of 2027-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Manuel Amaris, MD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT03886961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lung Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03886961 currently recruiting?
Yes, NCT03886961 is actively recruiting participants. Contact the research team at Vanessa.Scheuble@medicine.ufl.edu for enrollment information.
Where is the NCT03886961 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT03886961 clinical trial?
NCT03886961 is sponsored by University of Florida. The principal investigator is Manuel Amaris, MD at University of Florida. The trial plans to enroll 20 participants.