Lung TransplantReflux BandNCT03886961
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
A study testing Reflux Band in people with Lung Transplant and GERD, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplant, GERD
- What is being tested?
- Reflux Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2019to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
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.
- Conditions
- Lung Transplant, GERD
- Being tested
- Reflux Band
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflux BandDevice
Also called Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device
The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Reflux Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pepsin levels
The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid.
Measured: Baseline; Week 4; Week 8
Change in amylase levels
The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid.
Measured: Baseline; Week 4; Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start17 May 2019
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Somna Therapeutics, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Manuel Amaris, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886961
- Sponsor's protocol ID
- IRB201900469 -A
- Acronym
- Reflux Band
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT03886961
- Acronym / sponsor ID
- Reflux Band / IRB201900469 -A
- Conditions
- Lung Transplant, GERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Somna Therapeutics, L.L.C.
- Study start
- 17 May 2019 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Transplant Patients | Experimental | Device: Reflux BandFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflux BandAlso: Reflux Band™ Upper Esophageal Sphincter (UES) Assist DeviceThe Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant. | Device | Lung Transplant Patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manuel Amaris, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflux Band in people with Lung Transplant and GERD, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Scheuble (352-273-7589, Vanessa.Scheuble@medicine.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pepsin levels (time frame: Baseline; Week 4; Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.