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Reflux Band in Laryngopharyngeal Reflux
Sponsor: University of California, San Diego
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.
Official title: Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux (LPR)
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2021-05-07
Completion Date
2026-04-30
Last Updated
2025-04-08
Healthy Volunteers
No
Conditions
Interventions
External Upper Esophageal Sphincter (UES) Compression Device
External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.
Sham Device
External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.
Locations (1)
University of California, San Diego
La Jolla, California, United States