Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

Completed · Not applicable

Conditions studied: Laryngopharyngeal Reflux

In brief

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).

Key facts

Study ID

NCT01857713

Run by

Somna Therapeutics, L.L.C.

People needed

95

Starts

2013-04-01

Expected to finish

2013-09-01

Last updated by the study team

2015-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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