Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

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

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).

Study Overview

• Status: Completed
• Conditions: Laryngopharyngeal Reflux
• Intervention / Treatment: Device: Reza Band UES Assist Device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Madison ENT & Facial Plastic Surgery
    • New York, New York, United States, 10016
      • Dr. Alan Raymond
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research
    • Summit, Wisconsin, United States, 50366
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patients provide their perception of the device at the end of the study.	4 Weeks
Investigator Questionnaire	Investigators provide their perception of the device at the end of the study.	4 Weeks

Collaborators and Investigators

• Sponsor: Somna Therapeutics, L.L.C.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: May 20, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux
• Other Study ID Numbers: RB-001-02