Recruiting

Reflux Band™

Sponsor:

University of Florida

Code:

NCT03886961

Conditions

Lung Transplant

GERD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Reflux Band

Study Details

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.

Conditions

Lung Transplant

GERD

Study ID

NCT03886961

Start date

May 17, 2019

Status verified date

Jul, 2026

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Mar 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Reflux Band

The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.

Primary outcome measure

  • Change in pepsin levels [ Time Frame: Baseline; Week 4; Week 8 ]
  • Change in amylase levels [ Time Frame: Baseline; Week 4; Week 8 ]

Central Contacts and Locations

Central contacts

Vanessa Scheuble

352-273-7589Vanessa.Scheuble@medicine.ufl.edu

Locations

UF Health at the University of Florida

Recruiting

Gainesville, Florida, United States, 32610

More Information

Sponsor

University of Florida

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-13.