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NCT Number: NCT03886961

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

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.

Recruiting

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Key information

Conditions

Lung Transplant Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reflux Band

Device

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

Other names: Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device

Primary outcomes

  1. Change in pepsin levels

    Time frame: Baseline; Week 4; Week 8

    The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.

  2. Change in amylase levels

    Time frame: Baseline; Week 4; Week 8

    The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.

Study contacts

Contact information is provided by the study sponsor or research team.

Vanessa Scheuble

CONTACT

[email protected]

352-273-7589

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Somna Therapeutics, L.L.C.

Registry information

Acronym: Reflux Band

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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