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Clinical Trials/NCT03886961
NCT03886961RecruitingNot Applicable

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

University of Florida2 sites in 1 country20 target enrollmentStarted: May 17, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
2
Primary Endpoint
Change in pepsin levels
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Lung Transplant Patients

Experimental

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.

Intervention: Reflux Band (Device)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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