The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients

University of Florida

Status

Enrolling

Conditions

Lung Transplant

GERD

Treatments

Device: Reflux Band

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03886961

IRB201900469 -A

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Lung Transplant Patients

Experimental group

Description:

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.

Treatment:

Device: Reflux Band