Laryngopharyngeal RefluxNCT04827355
Reflux Band in Laryngopharyngeal Reflux
A study testing External Upper Esophageal Sphincter (UES) Compression Device in people with Laryngopharyngeal Reflux, run by University of California, San Diego at 1 site in United States.
Trial summary
This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Laryngopharyngeal Reflux
- What is being tested?
- External Upper Esophageal Sphincter (UES) Compression Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2021to 30 Apr 2026
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18-99, English or Spanish speaking
- ≥8 weeks of laryngeal symptoms (dysphonia, throat clearing, cough, globus, and/or sore throat)
- Current use of double daily dose acid suppression therapy (ex. omeprazole 40mg, omeprazole 20mg and famotidine 20mg)
- Laryngoscopic exam prior to screening with current symptoms
- At least 1 of the following:
- Elevated reflux testing
- Findings on upper endoscopy that are consistent with pathologic GERD
- Fasting pepsin analysis result of ≥25 ng/mL within 4 months of enrollment (12 months if treatment plan has not changed) *testing allowed at enrollment if not previously obtained
Who cannot join
- Prior use of Reflux Band (UES Compression Device)
- Sino-pulmonary conditions (such as asthma, COPD, post-nasal drip, heavy voice use) as primary etiology of laryngeal symptoms as deemed by treating gastroenterologist and / or laryngologist
- Laryngeal mass or lesion on laryngoscopy
- Pregnant or breastfeeding
- Unable to consent in English or Spanish
- Imprisoned
Show all 18Show fewer
- Patients with a prior foregut surgery
- Patients with a known achalasia diagnosis
- Inability to fast for 4 hours
- Active tobacco use
- Supplemental oxygen use
- Contraindication to UES Compression Device manufacturer guidelines:
- Patients with implants or implant parts that reside in the area where Reflux Band is applied: implanted pacemarker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator (VNS), or other such devices implanted in the neck
- Patients diagnosed with glaucoma.
- Patients who had a malignancy of the neck, including neck surgery.
- Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
- Patients with carotid artery disease, uncontrolled thyroid disease, a history of cerebrovascular disease, or connective tissue disorder of Marfan's Syndrome or Ehlers-Danlos Syndrome
- Patients who use nocturnal NIV machines such as CPAP or BiPAP.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92037
About this study
Official title: Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux (LPR)
This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be randomized to one of two arms: control or experimental. Following the 8 week intervention period subjects in both arms will continue in a 4 week unblinded period. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm.
Read the detailed description
This study seeks to understand if the Reflux Band is an effective treatment for laryngopharyngeal reflux (LPR) in comparison to a sham device. LPR is a syndrome in which acid that is made in the stomach travels up the esophagus and into the throat, causing chronic symptoms including throat clearing, voice hoarseness, sore throat, etc. Participation in the study may or may not benefit you directly, and may result in new knowledge that may help others.
Participation in this study involves: 3 - 4 in person visits (2 of which are part of standard of care) ranging from 30 - 45 minutes each and 2 virtual visits, either by phone or video, each 15 minutes. Participants are assigned with a 50/50 chance (similar to a coin flip) via a computer generator to receive the Reflux Band or sham device (a device that will not provide you medical therapy) which they will wear around their neck nightly while sleeping (6+ hours) over a duration of 8 weeks. The Reflux Band, which has been cleared for use by the FDA, applies pressure to the outside of the neck at the cricoid cartilage, at the middle of the neck, and increases the internal pressure of the muscle separating the throat from the esophagus (upper esophageal sphincter). Participants will only wear the band while sleeping at night and remove in the morning upon waking. The in person visits will occur at one of these UCSD La Jolla locations: the Perlman Medical Office Gastroenterology clinic, the Center for Voice and Swallowing, Altman Clinical and Translational Research Institute (ACTRI) Clinic.
There is an optional 4 week extension at the end of this study in which the Reflux Band will be refit (if sham) to provide the manufacturer's specified pressure. This portion contains 1 virtual follow up during week 10 and an in person follow up during week 12, at which time study participation will conclude.
The most commonly expected risks of the study are skin reaction, discomfort, and difficulty sleeping. These were generally mild and short in duration. No serious risks were observed when the Reflux Band was worn around the neck in previous studies.
- Conditions
- Laryngopharyngeal Reflux
- Being tested
- External Upper Esophageal Sphincter (UES) Compression Device, Sham Device
- Keywords
- Proton Pump Inhibitor (PPI), Upper Esophageal Sphincter (UES) Compression Device
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Upper Esophageal Sphincter (UES) Compression DeviceDevice
Also called Reflux Band, Reza Band
External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.
Sham DeviceDevice
External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Participants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention. Receives: Device: Sham Device |
| Experimental | Experimental | Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines. Receives: Device: External Upper Esophageal Sphincter (UES) Compression Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure response to the UES Compression Device in pepsin positive LPR.
Change in reflux symptom index score (primary outcome) between intervention versus sham arm will determine device efficacy.
Measured: 5 years
Secondary outcomes (1)
Measure pepsin response to the UES Compression Device in pepsin positive LPR.
Change in salivary pepsin concentration between pre and post treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start7 May 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of two arms: control or experimental. Randomization will be 1:1 to control (sham, known not to provide intervention) and experimental (fit to manufacturer guidelines).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rena Yadlapati, University of California, San Diego
- Investigators
- Rena Yadlapati, MD, MSHS, Principal investigator, UC San Diego Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827355
- Sponsor's protocol ID
- 201945
- Other IDs
- K23DK125266
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
PubMed 16928254Olson NR. Laryngopharyngeal manifestations of gastroesophageal reflux disease. Otolaryngol Clin North Am. 1991 Oct;24(5):1201-13.
PubMed 1754220Cohen SM, Pitman MJ, Noordzij JP, Courey M. Management of dysphonic patients by otolaryngologists. Otolaryngol Head Neck Surg. 2012 Aug;147(2):289-94. doi: 10.1177/0194599812440780. Epub 2012 Feb 24.
PubMed 22368039Ruiz R, Jeswani S, Andrews K, Rafii B, Paul BC, Branski RC, Amin MR. Hoarseness and laryngopharyngeal reflux: a survey of primary care physician practice patterns. JAMA Otolaryngol Head Neck Surg. 2014 Mar;140(3):192-6. doi: 10.1001/jamaoto.2013.6533.
PubMed 24481258Litvinov AV. [Method of tracheobronchial spraying of drugs in aerosols]. Vestn Khir Im I I Grek. 1976 Jan;116(1):100-1. No abstract available. Russian.
PubMed 1020172de Bortoli N, Nacci A, Savarino E, Martinucci I, Bellini M, Fattori B, Ceccarelli L, Costa F, Mumolo MG, Ricchiuti A, Savarino V, Berrettini S, Marchi S. How many cases of laryngopharyngeal reflux suspected by laryngoscopy are gastroesophageal reflux disease-related? World J Gastroenterol. 2012 Aug 28;18(32):4363-70. doi: 10.3748/wjg.v18.i32.4363.
PubMed 22969200Shaker R, Babaei A, Naini SR. Prevention of esophagopharyngeal reflux by augmenting the upper esophageal sphincter pressure barrier. Laryngoscope. 2014 Oct;124(10):2268-74. doi: 10.1002/lary.24735. Epub 2014 Jun 27.
PubMed 24782387Slivers SL, Vaezi MF, Vakil MB, et al. Prospective study of upper esophageal sphincter assist device for treating extraesophageal reflux. Otolaryngol Open J. 2016; 2(1): 31-38. doi: 10.17140/OTLOJ-2-109
Yadlapati R, Craft J, Adkins CJ, Pandolfino JE. The Upper Esophageal Sphincter Assist Device Is Associated With Symptom Response in Reflux-Associated Laryngeal Symptoms. Clin Gastroenterol Hepatol. 2018 Oct;16(10):1670-1672. doi: 10.1016/j.cgh.2018.01.031. Epub 2018 Jan 31.
PubMed 29408585Yadlapati R, Robles L, Clarke MK, Low EE, Walsh E, Krause AJ, Kaizer A. Randomized Controlled Trial of Upper Esophageal Sphincter Assist Device in Laryngopharyngeal Reflux Disease. Clin Gastroenterol Hepatol. 2026 Aug;24(8):2108-2117. doi: 10.1016/j.cgh.2025.12.015. Epub 2025 Dec 22.
PubMed 41443523
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux (LPR)
- ClinicalTrials.gov ID
- NCT04827355
- Acronym / sponsor ID
- 201945
- Conditions
- Laryngopharyngeal Reflux
- Keywords
- Proton Pump Inhibitor (PPI), Upper Esophageal Sphincter (UES) Compression Device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 Apr 2021 (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.
This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be randomized to one of two arms: control or experimental. Following the 8 week intervention period subjects in both arms will continue in a 4 week unblinded period. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm.
Detailed description
This study seeks to understand if the Reflux Band is an effective treatment for laryngopharyngeal reflux (LPR) in comparison to a sham device. LPR is a syndrome in which acid that is made in the stomach travels up the esophagus and into the throat, causing chronic symptoms including throat clearing, voice hoarseness, sore throat, etc. Participation in the study may or may not benefit you directly, and may result in new knowledge that may help others.
Participation in this study involves: 3 - 4 in person visits (2 of which are part of standard of care) ranging from 30 - 45 minutes each and 2 virtual visits, either by phone or video, each 15 minutes. Participants are assigned with a 50/50 chance (similar to a coin flip) via a computer generator to receive the Reflux Band or sham device (a device that will not provide you medical therapy) which they will wear around their neck nightly while sleeping (6+ hours) over a duration of 8 weeks. The Reflux Band, which has been cleared for use by the FDA, applies pressure to the outside of the neck at the cricoid cartilage, at the middle of the neck, and increases the internal pressure of the muscle separating the throat from the esophagus (upper esophageal sphincter). Participants will only wear the band while sleeping at night and remove in the morning upon waking. The in person visits will occur at one of these UCSD La Jolla locations: the Perlman Medical Office Gastroenterology clinic, the Center for Voice and Swallowing, Altman Clinical and Translational Research Institute (ACTRI) Clinic.
There is an optional 4 week extension at the end of this study in which the Reflux Band will be refit (if sham) to provide the manufacturer's specified pressure. This portion contains 1 virtual follow up during week 10 and an in person follow up during week 12, at which time study participation will conclude.
The most commonly expected risks of the study are skin reaction, discomfort, and difficulty sleeping. These were generally mild and short in duration. No serious risks were observed when the Reflux Band was worn around the neck in previous studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to one of two arms: control or experimental. Randomization will be 1:1 to control (sham, known not to provide intervention) and experimental (fit to manufacturer guidelines).
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: Sham DeviceParticipants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention. |
| Experimental | Experimental | Device: External Upper Esophageal Sphincter (UES) Compression DeviceParticipants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults between 18-99, English or Spanish speaking
- ≥8 weeks of laryngeal symptoms (dysphonia, throat clearing, cough, globus, and/or sore throat)
- Current use of double daily dose acid suppression therapy (ex. omeprazole 40mg, omeprazole 20mg and famotidine 20mg)
- Laryngoscopic exam prior to screening with current symptoms
- At least 1 of the following:
Key exclusion criteria (18 listed)
- Prior use of Reflux Band (UES Compression Device)
- Sino-pulmonary conditions (such as asthma, COPD, post-nasal drip, heavy voice use) as primary etiology of laryngeal symptoms as deemed by treating gastroenterologist and / or laryngologist
- Laryngeal mass or lesion on laryngoscopy
- Pregnant or breastfeeding
- Unable to consent in English or Spanish
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 |
|---|---|---|
| External Upper Esophageal Sphincter (UES) Compression DeviceAlso: Reflux Band, Reza BandExternal Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines. | Device | Experimental |
| Sham DeviceExternal Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment. | Device | Control |
Primary outcome
Measure response to the UES Compression Device in pepsin positive LPR.
Time frame: 5 years
Change in reflux symptom index score (primary outcome) between intervention versus sham arm will determine device efficacy.
1 secondary outcome
Measure pepsin response to the UES Compression Device in pepsin positive LPR.
Time frame: 5 years
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 8 Apr 2025.
- Background: PubMed 16928254Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
- Background: PubMed 1754220Olson NR. Laryngopharyngeal manifestations of gastroesophageal reflux disease. Otolaryngol Clin North Am. 1991 Oct;24(5):1201-13.
- Background: PubMed 22368039Cohen SM, Pitman MJ, Noordzij JP, Courey M. Management of dysphonic patients by otolaryngologists. Otolaryngol Head Neck Surg. 2012 Aug;147(2):289-94. doi: 10.1177/0194599812440780. Epub 2012 Feb 24.
- Background: PubMed 24481258Ruiz R, Jeswani S, Andrews K, Rafii B, Paul BC, Branski RC, Amin MR. Hoarseness and laryngopharyngeal reflux: a survey of primary care physician practice patterns. JAMA Otolaryngol Head Neck Surg. 2014 Mar;140(3):192-6. doi: 10.1001/jamaoto.2013.6533.
- Background: PubMed 1020172Litvinov AV. [Method of tracheobronchial spraying of drugs in aerosols]. Vestn Khir Im I I Grek. 1976 Jan;116(1):100-1. No abstract available. Russian.
- Background: PubMed 22969200de Bortoli N, Nacci A, Savarino E, Martinucci I, Bellini M, Fattori B, Ceccarelli L, Costa F, Mumolo MG, Ricchiuti A, Savarino V, Berrettini S, Marchi S. How many cases of laryngopharyngeal reflux suspected by laryngoscopy are gastroesophageal reflux disease-related? World J Gastroenterol. 2012 Aug 28;18(32):4363-70. doi: 10.3748/wjg.v18.i32.4363.
- Results publication: PubMed 24782387Shaker R, Babaei A, Naini SR. Prevention of esophagopharyngeal reflux by augmenting the upper esophageal sphincter pressure barrier. Laryngoscope. 2014 Oct;124(10):2268-74. doi: 10.1002/lary.24735. Epub 2014 Jun 27.
- Results publicationSlivers SL, Vaezi MF, Vakil MB, et al. Prospective study of upper esophageal sphincter assist device for treating extraesophageal reflux. Otolaryngol Open J. 2016; 2(1): 31-38. doi: 10.17140/OTLOJ-2-109
- Results publication: PubMed 29408585Yadlapati R, Craft J, Adkins CJ, Pandolfino JE. The Upper Esophageal Sphincter Assist Device Is Associated With Symptom Response in Reflux-Associated Laryngeal Symptoms. Clin Gastroenterol Hepatol. 2018 Oct;16(10):1670-1672. doi: 10.1016/j.cgh.2018.01.031. Epub 2018 Jan 31.
- Derived from this study: PubMed 41443523Yadlapati R, Robles L, Clarke MK, Low EE, Walsh E, Krause AJ, Kaizer A. Randomized Controlled Trial of Upper Esophageal Sphincter Assist Device in Laryngopharyngeal Reflux Disease. Clin Gastroenterol Hepatol. 2026 Aug;24(8):2108-2117. doi: 10.1016/j.cgh.2025.12.015. Epub 2025 Dec 22.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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. This study is not recruiting at the moment.
Rena Yadlapati, MD, MSHS principal investigator
UC San Diego Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Upper Esophageal Sphincter (UES) Compression Device in people with Laryngopharyngeal Reflux, run by University of California, San Diego 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 8 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure response to the UES Compression Device in pepsin positive LPR. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827355, which also lists 10 linked publications.
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 8 Apr 2025.