Active — Not RecruitingNot Applicable

Reflux Band in Laryngopharyngeal Reflux

United States72 participantsStarted 2021-05-07

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 dev…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 5 years

Trial details

NCT IDNCT04827355

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Laryngopharyngeal Reflux trials