Reflux Band in Laryngopharyngeal Reflux

NCT04827355 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 201945K23DK125266
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Laryngopharyngeal Reflux

Keywords

Proton Pump Inhibitor (PPI); Upper Esophageal Sphincter (UES) Compression Device

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (1)

• Measure pepsin response to the UES Compression Device in pepsin positive LPR.

  5 years

Study Arms (2)

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.

Device: Sham Device

Experimental

EXPERIMENTAL

Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.

Device: External Upper Esophageal Sphincter (UES) Compression Device

Interventions

External Upper Esophageal Sphincter (UES) Compression Device DEVICE

External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.

Also known as: Reflux Band, Reza Band

Experimental

Sham Device DEVICE

External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Related Publications (10)

• 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.

  PMID: 16928254 BACKGROUND

• Olson NR. Laryngopharyngeal manifestations of gastroesophageal reflux disease. Otolaryngol Clin North Am. 1991 Oct;24(5):1201-13.

  PMID: 1754220 BACKGROUND

• Cohen 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.

  PMID: 22368039 BACKGROUND

• Ruiz 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.

  PMID: 24481258 BACKGROUND

• Litvinov 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.

  PMID: 1020172 BACKGROUND

• de 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.

  PMID: 22969200 BACKGROUND

• Shaker 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.

  PMID: 24782387 RESULT

• Slivers 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

  RESULT

• 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.

  PMID: 29408585 RESULT

• Yadlapati 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. 2025 Dec 22:S1542-3565(25)01062-6. doi: 10.1016/j.cgh.2025.12.015. Online ahead of print.

  PMID: 41443523 DERIVED

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Study Officials

• Rena Yadlapati, MD, MSHS

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Model Details: 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).

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 7, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)