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

Last updated: September 30, 2024
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Reflux Band

Clinical Study ID

NCT03886961
IRB201900469 -A
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Clinically stable lung transplant patients(single lung, double lung, orre-transplant) as defined by stable FEV1 over the prior two visits

  • 13 Abnormal pH impedence or esophagram or documented gastric reflux atpre-transplant evaluation

  • Patient must be willing and able to provide informed consent

  • Understands the clinical study requirements and is able to comply with follow-upschedule

Exclusion

Exclusion Criteria:

  • Currently being treated with another investigational medical device and/or drug

  • Currently receiving treatment for sleep apnea with continuous positive airwaypressure (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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Reflux Band
Phase:
Study Start date:
May 17, 2019
Estimated Completion Date:
March 20, 2025

Connect with a study center

  • UF Health at the University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

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