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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks