The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Reflux Band
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Florida
Lead sponsor
Somna Therapeutics, L.L.C.
Collaborator
Source ClinicalTrials.gov