Recruiting NCT03886961
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reflux Band.
- Who it may be relevant to
- Registry conditions: Lung Transplant, GERD. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Reflux Band
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
Primary outcome measures
- Change in pepsin levels [Time frame: Baseline; Week 4; Week 8]
- Change in amylase levels [Time frame: Baseline; Week 4; Week 8]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UF Health at the University of Florida — Gainesville
Identifiers
NCT: NCT03886961 · IRB201900469 -A