An interventional study of External Upper Esophageal Sphincter (UES) Compression Device and Sham Device in Laryngopharyngeal Reflux, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
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.
1,066 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 72 is close to the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
At least 1 of the following:
Exclusion Criteria:
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
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
External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.
Also known as: Reflux Band, Reza Band
External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.
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.
Time frame: 5 years
Measure pepsin response to the UES Compression Device in pepsin positive LPR.
Change in salivary pepsin concentration between pre and post treatment.
Time frame: 5 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — IPD will not be shared with other researchers.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of California, San Diego