Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT03886961

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

UF Health at the University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

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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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