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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT03886961
Status
Recruiting
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Conditions

  • GERD
  • Lung Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 17, 2019
Status verified
Jun 2025
Primary completion
Mar 20, 2027
Completion
Dec 20, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health at the University of FloridaGainesvilleFlorida32610-

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By research site
UF Health at the University of Florida· Gainesville, FL

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