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N/A N=95 Prevention

Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

Laryngopharyngeal Reflux

Bottom Line

View on ClinicalTrials.gov: NCT01857713 ↗
Enrolled (actual)
95
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks — -54.3 Per Cent Change — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Reza Band UES Assist Device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Somna Therapeutics, L.L.C.
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks		 -54.3 <0.05 sig
PRIMARY
Primary Safety		 58.6 —
SECONDARY
SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score		 0.56 —
SECONDARY
Functional Outcomes of Sleep Questionnaire (FOSQ)		 0.80 —

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).

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01857713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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