Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
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ClinicalTrials.gov Identifier: NCT03619811 |
Recruitment Status :
Completed
First Posted : August 8, 2018
Results First Posted : September 20, 2021
Last Update Posted : September 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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Gastroesophageal Reflux Laryngopharyngeal Reflux | Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | N/A |
Intervention Model: | Single Group 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 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |
Arm | Intervention/treatment |
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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. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
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Diagnostic Test: Reflux 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. |
- Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score [ Time Frame: Week 8 (Completion) ]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 [ Time Frame: 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.

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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 |
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;
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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.

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
United States, California | |
University of California, San Diego | |
La Jolla, California, United States, 92037 |
Principal Investigator: | Rena Yadlapati, M.D. | University of California, San Diego |
Documents provided by Rena Yadlapati, University of California, San Diego:
Responsible Party: | Rena Yadlapati, Principal Investigator, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03619811 |
Other Study ID Numbers: |
18-0205 |
First Posted: | August 8, 2018 Key Record Dates |
Results First Posted: | September 20, 2021 |
Last Update Posted: | September 20, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
esophageal disorders |
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 |