NCT03619811

Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.

Detailed description

Reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.

Conditions

• Gastroesophageal Reflux
• Laryngopharyngeal Reflux

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Reflux Band® Upper Esophageal Sphincter (UES) Assist Device	UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.

Timeline

• Start date: 2018-07-13
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-08-08
• Last updated: 2021-09-20
• Results posted: 2021-09-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study