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
• Interventions: Device: Reflux Band

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung Transplant Patients	Reflux Band	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.

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