Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

Not Applicable

Completed

• Conditions: Laryngopharyngeal Reflux; Gastroesophageal Reflux
• Interventions: Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device

• Registration Number: NCT03619811
• Lead Sponsor: University of California, San Diego

Brief 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.

Study Timeline

• Study Start: 2018-07-13
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Results First Submitted: 2021-08-23
• Results First Submitted QC: 2021-08-23
• Last Update Submitted: 2021-08-23
• Results First Posted: 2021-09-20
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Age 18-89 years male and female,
• >8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness,
• naïve to PPI or able to stop for 8 weeks

Exclusion Criteria

• Laryngeal mass lesion on laryngoscopy;

• Pregnant;

• Unable to consent in English;

• Imprisoned;

• PPI intolerance;

• Contraindication to UESAD use per manufacturer guidelines which include:

  • Patients with implants or implant parts that reside in the area where UESAD is applied.
  • Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
  • Patients diagnosed with glaucoma.
  • Patients who had a malignancy of the neck, including neck surgery.
  • Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
  • Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
  • Patients who use nocturnal NIV machines such as CPAP or BiPAP.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symptomatic	Reflux Band® Upper Esophageal Sphincter (UES) Assist Device	This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)

Primary Outcome Measures

Name	Time	Method
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score	Week 4	Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States