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Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

Primary Purpose

Gastroesophageal Reflux, Laryngopharyngeal Reflux

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux focused on measuring esophageal disorders

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Symptomatic

Arm 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)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2018
Last Updated
August 23, 2021
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03619811
Brief Title
Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Official Title
Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Laryngopharyngeal Reflux
Keywords
esophageal disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic
Arm Type
Experimental
Arm 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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Description
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.
Time Frame
Week 8 (Completion)
Title
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Description
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.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena Yadlapati, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34275061
Citation
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.
Results Reference
derived

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Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

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