NCT01857713

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 21, 2015

Completed
Last Updated

June 19, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

May 16, 2013

Results QC Date

December 17, 2013

Last Update Submit

May 20, 2015

Conditions

Laryngopharyngeal Reflux

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score

    4 Weeks minus Baseline

  • Functional Outcomes of Sleep Questionnaire (FOSQ)

    4 Weeks minus Baseline

Other Outcomes (2)

  • Patient Satisfaction

    4 Weeks

  • Investigator Questionnaire

    4 Weeks

Study Arms (1)

Reza Band UES Assist Device

ACTIVE COMPARATOR

Patient is own control. Compare baseline to last follow-up after using device

Device: Reza Band UES Assist Device

Interventions

Reza Band UES Assist DeviceDEVICE

Device is worn by patient to reduce or eliminate laryngopharyngeal reflux

Reza Band UES Assist Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dr. Alan Raymond

New York, New York, 10016, United States

Location

Madison ENT & Facial Plastic surgery

New York, New York, 10016, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Aurora Health Care

Summit, Wisconsin, 50366, United States

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
James Miller
Organization
Somna Therapeutics, L.L.C.
jmiller@somnatherapeutics.com
262-345-5553

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 20, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 19, 2015

Results First Posted

May 21, 2015

Record last verified: 2015-05

Locations

US(5)