Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/3/2013
Start Date:April 2013
End Date:July 2013
Contact:James S Miller
Email:jmiller@somnatherapeutics.com
Phone:262-345-5553

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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).


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
We found this trial at
3
sites
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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