Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

NCT03619811 | Completed Results FDA Device

• 1 other identifier: 18-0205
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroesophageal Reflux; Laryngopharyngeal Reflux

Keywords

esophageal disorders

Outcome Measures

Primary Outcomes (2)

• Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score

  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.

  Week 8 (Completion)

• Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score

  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.

  Week 4

Study Arms (1)

Symptomatic

EXPERIMENTAL

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)

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

Interventions

Reflux Band® Upper Esophageal Sphincter (UES) Assist Device DIAGNOSTIC_TEST

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.

Symptomatic

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Yadlapati R, Pandolfino JE, Greytak M, Cahoon J, Clarke M, Clary M, Fink D, Menard-Katcher P, Vahabzadeh-Hagh AM, Weissbrod P, Gupta S, Kaizer A, Wani S. Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. Dig Dis Sci. 2022 Jul;67(7):3045-3054. doi: 10.1007/s10620-021-07172-2. Epub 2021 Jul 18.

  PMID: 34275061 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Laryngopharyngeal Reflux; Esophageal Diseases

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: UCSD

mgreytak@ucsd.edu

858-246-5236

Study Officials

• Rena Yadlapati, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 8, 2018
• Study Start: July 13, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 20, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)