Status:
COMPLETED
Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device
Lead Sponsor:
Somna Therapeutics, L.L.C.
Conditions:
Laryngopharyngeal Reflux
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01857713
Start Date
April 1 2013
End Date
September 1 2013
Last Update
June 19 2015
Active Locations (5)
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1
Dr. Alan Raymond
New York, New York, United States, 10016
2
Madison ENT & Facial Plastic surgery
New York, New York, United States, 10016
3
Vanderbilt University
Nashville, Tennessee, United States, 37212
4
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215