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Could a simple neck band protect transplanted lungs from stomach acid?

NCT ID NCT03886961

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether a device worn around the neck during sleep can reduce reflux in people who have received a lung transplant. Reflux can damage the new lungs, so researchers are measuring levels of stomach enzymes in lung fluid to see if the device helps. The trial involves 20 stable lung transplant patients who will use the Reflux Band for 4 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Reflux Band (a wearable device that supports the upper esophageal sphincter)
What this could lead to
If effective, this device could offer a non-drug way to manage reflux after lung transplant, potentially protecting the transplanted lungs from damage.
What could go wrong
This is a small, early study with only 20 participants, so results may not apply to all patients. The device may be uncomfortable or fail to reduce reflux significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GERD Lung transplant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UF Health at the University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

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