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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Reflux Band
DeviceThe Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Lung Transplant PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pepsin levels
The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.
Time frame
Baseline; Week 4; Week 82
Change in amylase levels
The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.
Time frame
Baseline; Week 4; Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
Somna Therapeutics, L.L.C.
Collaborator
Source ClinicalTrials.gov