The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients (Reflux Band)

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.

Study Overview

• Status: Recruiting
• Conditions: GERD; Lung Transplant
• Intervention / Treatment: Device: Reflux Band

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Scheuble; Phone Number: 352-273-7589; Email: Vanessa.Scheuble@medicine.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • UF Health at the University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung Transplant Patients; For the first four weeks, lung transplant patients will not wear the Reflux Band. Use of the Reflux Band will subsequently commence in the next four weeks.	Device: Reflux Band; The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.; Other Names: Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pepsin levels	The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.	Baseline; Week 4; Week 8
Change in amylase levels	The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.	Baseline; Week 4; Week 8

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Somna Therapeutics, L.L.C.
• Investigators: Principal Investigator: Manuel Amaris, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB201900469 -A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes