The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Reflux Band
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedStudy Start
First participant enrolled
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2027
July 16, 2025
June 1, 2025
7.8 years
March 21, 2019
July 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Lung Transplant Patients
EXPERIMENTALFor 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.
Interventions
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
Eligibility Criteria
You may qualify if:
- Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Somna Therapeutics, L.L.C.collaborator
Study Sites (1)
UF Health at the University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuel Amaris, MD
University of Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 22, 2019
Study Start
May 17, 2019
Primary Completion (Estimated)
March 20, 2027
Study Completion (Estimated)
December 20, 2027
Last Updated
July 16, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share