Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device (NCT01857713) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device
United States95 participantsStarted 2013-04
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks