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Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857713
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : May 21, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Somna Therapeutics, L.L.C.

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).

Condition or disease Intervention/treatment Phase
Laryngopharyngeal Reflux Device: Reza Band UES Assist Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : April 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Reza Band UES Assist Device
Patient is own control. Compare baseline to last follow-up after using device
Device: Reza Band UES Assist Device
Device is worn by patient to reduce or eliminate laryngopharyngeal reflux




Primary Outcome Measures :
  1. Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks [ Time Frame: 4 Weeks minus Baseline ]
    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).

  2. Primary Safety [ Time Frame: 4 Week Follow-up ]
    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.


Secondary Outcome Measures :
  1. SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score [ Time Frame: 4 Weeks minus Baseline ]
    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.

  2. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 4 Weeks minus Baseline ]
    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.


Other Outcome Measures:
  1. Patient Satisfaction [ Time Frame: 4 Weeks ]
    Patients provide their perception of the device at the end of the study.

  2. Investigator Questionnaire [ Time Frame: 4 Weeks ]
    Investigators provide their perception of the device at the end of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857713


Locations
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United States, New York
Dr. Alan Raymond
New York, New York, United States, 10016
Madison ENT & Facial Plastic surgery
New York, New York, United States, 10016
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Aurora Health Care
Summit, Wisconsin, United States, 50366
Sponsors and Collaborators
Somna Therapeutics, L.L.C.
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Responsible Party: Somna Therapeutics, L.L.C.
ClinicalTrials.gov Identifier: NCT01857713    
Other Study ID Numbers: RB-001-02
First Posted: May 20, 2013    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: June 19, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases