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

Not Applicable

Recruiting

• Conditions: Lung Transplant; GERD

• Registration Number: NCT03886961
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-05-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-16
• Primary Completion: 2027-03-20
• Study Completion: 2027-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States