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Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

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ClinicalTrials.gov Identifier: NCT03619811
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Rena Yadlapati, 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Laryngopharyngeal Reflux Diagnostic Test: Reza Band® Upper Esophageal Sphincter (UES) Assist Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
No Intervention: Healthy Subject
This research study is looking at the diagnosis and treatment of Reflux associated laryngeal symptoms. In order to do this, healthy subjects are needed to act as the baseline to compare with people who have Reflux associated laryngeal symptoms
Experimental: Symptomatic
This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reza Band® Upper Esophageal Sphincter (UES) Assist Device)
Diagnostic Test: Reza 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.




Primary Outcome Measures :
  1. Patient-reported symptom response to treatment measured by the reflux symptom index (RSI) score [ Time Frame: Through completion (Score measured at Baseline, Week 4, and Week 8) ]
    Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment RSI score ≤ 13 and a 33% change from comparator RSI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Reflux Associated Laryngeal Symptoms (RALS) Subject Cohort:

    • 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,
    • Laryngoscopy performed within 3 months without any laryngeal mass.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619811


Contacts
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Contact: Jonathon Cahoon, B.A. 303-724-8974 ext 49228 JONATHON.CAHOON@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Zoe Van Doorde    303-724-9228      
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Paul Menard-Katcher, M.D. University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by Rena Yadlapati, University of California, San Diego:

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Responsible Party: Rena Yadlapati, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03619811     History of Changes
Other Study ID Numbers: 18-0205
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Rena Yadlapati, University of California, San Diego:
esophageal disorders
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Laryngeal Diseases
Respiratory Tract Diseases