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Reflux Band in Laryngopharyngeal Reflux

NCT04827355 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-04-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Rena Yadlapati, MD, MSHS · UC San Diego Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04827355 on ClinicalTrials.gov