Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

University of California San Diego

Status: Completed

Conditions: Gastroesophageal Reflux; Laryngopharyngeal Reflux

Treatments: Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03619811

18-0205

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Symptomatic

Experimental group

Description:

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)

Treatment:

Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device