GERD, Lung Transplant
Conditions
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.
Interventions
DEVICEReflux Band
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
Sponsors
University of Florida
Somna Therapeutics, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pepsin levels | Baseline; Week 4; Week 8 | The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid. |
| Change in amylase levels | Baseline; Week 4; Week 8 | The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid. |
Countries
United States
Contacts
CONTACTVanessa Scheuble
PRINCIPAL_INVESTIGATORManuel Amaris, MD
University of Florida
Outcome results
None listed