The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
NCT ID: NCT03886961
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2019-05-17
2027-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Lung Transplant Patients
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.
Reflux Band
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
Interventions
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Reflux Band
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Somna Therapeutics, L.L.C.
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Manuel Amaris, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Health at the University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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IRB201900469 -A
Identifier Type: -
Identifier Source: org_study_id
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