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NCT03886961 Clinical Trial

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

GERD Clinical Trial

— Reflux Band  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03886961
Other study ID # IRB201900469 -A
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 17, 2019
Est. completion date March 20, 2025

Study information
Verified date August 2023
Source University of Florida
Contact Vanessa Scheuble
Phone 352-273-7589
Email Vanessa.Scheuble@medicine.ufl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 20, 2025
Est. primary completion date March 20, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Reflux Band
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.

Locations
Country Name City State
United States UF Health at the University of Florida Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Florida Somna Therapeutics, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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