Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

Laryngopharyngeal Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857713
• Other study ID #: RB-001-02
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: May 20, 2015
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: Somna Therapeutics, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laryngopharyngeal Reflux

Intervention

Device:
• Reza Band UES Assist Device
Device is worn by patient to reduce or eliminate laryngopharyngeal reflux

Locations

Country	Name	City	State
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Dr. Alan Raymond	New York	New York
United States	Madison ENT & Facial Plastic surgery	New York	New York
United States	Aurora Health Care	Summit	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Somna Therapeutics, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction	Patients provide their perception of the device at the end of the study.	4 Weeks	No
Other	Investigator Questionnaire	Investigators provide their perception of the device at the end of the study.	4 Weeks	No
Primary	Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks	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).	4 Weeks minus Baseline	No
Primary	Primary Safety	Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.	4 Week Follow-up	Yes
Secondary	SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	4 Weeks minus Baseline	No
Secondary	Functional Outcomes of Sleep Questionnaire (FOSQ)	The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.	4 Weeks minus Baseline	No