Clinical trial NCT01857713: Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device
Official title: A Multi-Center, Non-Randomized, Prospective Study of the Reza Band™ Upper Esophageal Sphincter (UES) Assist Device for the Treatment of Esophagopharyngeal Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngopharyngeal Reflux
Lead sponsor: Somna Therapeutics, L.L.C.
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

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 cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing). Reza Band is to be worn when sleeping. The patient will put the Reza Band on at bedtime and take it off upon waking.

This is a prospective, non-randomized, open label, multicenter study designed to assess the safety and effectiveness of the Reza Band. At up to 5 investigational sites, up to 100 subjects will be enrolled.

The primary effectiveness endpoint is to be evaluated by the Reflux Symptom Index (RSI). Success is defined as \>25% reduction in the RSI at the last follow-up, as compared to the baseline RSI. The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45.

All adverse reactions being reported will be evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band. Since some subjects may report the same event several times (e.g., redness), the first occurrence of the worst reported case of the event will be used for the purpose of analysis.

The incidence of site reactions, including laryngospasm, choking, pain, cough and hoarseness will be summarized. Exact 95% confidence intervals for the incidence rate of site reactions will be presented.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks
timeFrame: 4 Weeks minus Baseline
measure: Primary Safety
timeFrame: 4 Week Follow-up
Secondary outcomes:
measure: SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score
timeFrame: 4 Weeks minus Baseline
measure: Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 4 Weeks minus Baseline
Other outcomes:
measure: Patient Satisfaction
timeFrame: 4 Weeks
measure: Investigator Questionnaire
timeFrame: 4 Weeks
Locations:
city: New York
country: United States
facility: Dr. Alan Raymond
state: New York
city: New York
country: United States
facility: Madison ENT & Facial Plastic surgery
state: New York
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Summit
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
References: