RECRUITING

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

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Conditions

Lung TransplantGERD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-05-17
Study Completion:2025-03-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03886961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits
  2. * 13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation
  3. * Patient must be willing and able to provide informed consent
  4. * Understands the clinical study requirements and is able to comply with follow-up schedule
  1. * Currently being treated with another investigational medical device and/or drug
  2. * Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
  3. * Previous head or neck surgery / radiation
  4. * Carotid artery disease, thyroid disease, or history of cerebral vascular disease
  5. * Nasopharyngeal cancer
  6. * Suspected esophageal cancer

Contacts and Locations

Study Contact

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

Principal Investigator

Manuel Amaris, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

UF Health at the University of Florida
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Manuel Amaris, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-17
Study Completion Date2025-03-20

Study Record Updates

Study Start Date2019-05-17
Study Completion Date2025-03-20

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Transplant
  • GERD