The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
UF Health at the University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Vanessa Scheuble
Vanessa.Scheuble@medicine.ufl.edu
352-273-7589
Time Frame
Start Date: 2019-05-17
Estimated Completion Date: 2027-12-20
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Authors
Andres Pelaez Freidel
Related Therapeutic Areas
Sponsors
Leads: University of Florida
Collaborators: Somna Therapeutics, L.L.C.