Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device
NCT ID: NCT01857713
Last Updated: 2015-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2013-04-30
2013-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Reza Band UES Assist Device
Patient is own control. Compare baseline to last follow-up after using device
Reza Band UES Assist Device
Device is worn by patient to reduce or eliminate laryngopharyngeal reflux
Interventions
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Reza Band UES Assist Device
Device is worn by patient to reduce or eliminate laryngopharyngeal reflux
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Somna Therapeutics, L.L.C.
INDUSTRY
Responsible Party
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Locations
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Dr. Alan Raymond
New York, New York, United States
Madison ENT & Facial Plastic surgery
New York, New York, United States
Vanderbilt University
Nashville, Tennessee, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Aurora Health Care
Summit, Wisconsin, United States
Countries
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Other Identifiers
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RB-001-02
Identifier Type: -
Identifier Source: org_study_id
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