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Behavioural Intervention

Reflux Band for Acid Reflux in Lung Transplant Patients (Reflux Band Trial)

N/A

Recruiting

Led By Manuel Amaris, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

History of cerebral vascular disease

Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; week 4; week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a device called the Reflux Band can help reduce acid reflux in people who have had a lung transplant.

Who is the study for?

This trial is for lung transplant recipients who have acid reflux, as shown by tests before their transplant. They must understand and agree to the study's process and follow-up visits. Stable lung function after the transplant is required. People with recent head or neck surgery, thyroid disease, certain cancers, carotid artery disease, or a history of stroke can't join.

What is being tested?

The study is testing the Reflux Band™ UES Assist Device on patients who've had a lung transplant to see if it helps control their acid reflux symptoms. It's an open-label trial where all participants will use the device and be monitored for its effects.

What are the potential side effects?

While not explicitly listed in your information provided, potential side effects may include discomfort at the site of wearing the device, possible skin irritation from contact with the band material, or difficulty swallowing if too much pressure is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung function has been stable since my last two doctor visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or other brain blood vessel issues.

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I am using a CPAP machine for my sleep apnea.

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I might have esophageal cancer.

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I am currently participating in another clinical trial.

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I have had surgery or radiation on my head or neck.

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I have cancer in the upper part of my throat behind the nose.

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I have carotid artery disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; week 4; week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; week 4; week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 4; week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in amylase levels

Change in pepsin levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lung Transplant PatientsExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met