Actively Recruiting
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Led by University of Florida · Updated on 2025-07-16
20
Participants Needed
1
Research Sites
448 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
S
Somna Therapeutics, L.L.C.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically stable lung transplant patients (single lung, double lung, or re-transplant) with stable FEV1 over prior two visits
- Documented abnormal pH impedance, esophagram, or gastric reflux at pre-transplant evaluation
- Willing and able to provide informed consent
- Understands study requirements and can comply with follow-up schedule
You will not qualify if you...
- Currently being treated with another investigational medical device or drug
- Receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
- Previous head or neck surgery or radiation
- History of carotid artery disease, thyroid disease, or cerebral vascular disease
- Nasopharyngeal cancer
- Suspected esophageal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
V
Vanessa Scheuble
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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