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