Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device
|ClinicalTrials.gov Identifier: NCT01857713|
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : May 21, 2015
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Laryngopharyngeal Reflux||Device: Reza Band UES Assist Device||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Non-Randomized, Prospective Study of the Reza Band™ Upper Esophageal Sphincter (UES) Assist Device for the Treatment of Esophagopharyngeal Reflux|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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
- Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks [ Time Frame: 4 Weeks minus Baseline ]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).
- Primary Safety [ Time Frame: 4 Week Follow-up ]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.
- SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score [ Time Frame: 4 Weeks minus Baseline ]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.
- Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 4 Weeks minus Baseline ]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.
- Patient Satisfaction [ Time Frame: 4 Weeks ]Patients provide their perception of the device at the end of the study.
- Investigator Questionnaire [ Time Frame: 4 Weeks ]Investigators provide their perception of the device at the end of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857713
|United States, New York|
|Dr. Alan Raymond|
|New York, New York, United States, 10016|
|Madison ENT & Facial Plastic surgery|
|New York, New York, United States, 10016|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37212|
|United States, Wisconsin|
|Wisconsin Center for Advanced Research|
|Milwaukee, Wisconsin, United States, 53215|
|Aurora Health Care|
|Summit, Wisconsin, United States, 50366|