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ACTIVE NOT RECRUITING
NCT04827355
NA

Reflux Band in Laryngopharyngeal Reflux

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

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

Interventions

DEVICE

External Upper Esophageal Sphincter (UES) Compression Device

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

DEVICE

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