Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

Detailed Description
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The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing). Reza Band is to be worn when sleeping. The patient will put the Reza Band on at bedtime and take it off upon waking. This is a prospective, non-randomized, open label, multicenter study designed to assess the safety and effectiveness of the Reza Band. At up to 5 investigational sites, up to 100 subjects will be enrolled. The primary effectiveness endpoint is to be evaluated by the Reflux Symptom Index (RSI). Success is defined as >25% reduction in the RSI at the last follow-up, as compared to the baseline RSI. The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45. All adverse reactions being reported will be evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band. Since some subjects may report the same event several times (e.g., redness), the first occurrence of the worst reported case of the event will be used for the purpose of analysis. The incidence of site reactions, including laryngospasm, choking, pain, cough and hoarseness will be summarized. Exact 95% confidence intervals for the incidence rate of site reactions will be presented.

Official Title
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A Multi-Center, Non-Randomized, Prospective Study of the Reza Band™ Upper Esophageal Sphincter (UES) Assist Device for the Treatment of Esophagopharyngeal Reflux

Conditions
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Laryngopharyngeal Reflux

Intervention / Treatment
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* Device: Reza Band UES Assist Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 year of age or older The patient must be willing and able to provide informed consent. Understands the clinical study requirements and is able to comply with follow-up schedule. Clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing) Reflux Symptom Index (RSI) >13 Exclusion Criteria: Currently being treated with another investigational medical device and/or drug Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP) The patient is female and is of child bearing potential and is not using an acceptable method of birth control, or is pregnant or breast feeding. Previous head or neck surgery or radiation Carotid artery disease, thyroid disease, or history of cerebral vascular disease Suspected esophageal cancer Has either a pacemaker or implanted cardioverter defibrillator (ICD) Nasopharyngeal cancer Previously undergone Nissen Fundoplication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reza Band UES Assist Device<br>Patient is own control. Compare baseline to last follow-up after using device | Device: Reza Band UES Assist Device<br>* Device is worn by patient to reduce or eliminate laryngopharyngeal reflux<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks | The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45). | 4 Weeks minus Baseline | 
| Primary Safety | Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device. | 4 Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 4 Weeks minus Baseline | 
| Functional Outcomes of Sleep Questionnaire (FOSQ) | The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons. | 4 Weeks minus Baseline |