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 |
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
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