CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
UESADdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02552966
NCT02552966N/ACompleted
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Assessing the Impacts of an Upper Esophageal Sphincter Assist Device on Laryngeal Symptoms and Salivary Pepsin: A Pilot Study

Northwestern University·interventional·Posted Sep 17, 2015·Updated Feb 26, 2020

In Brief

A clinical study evaluating UESAD for Laryngopharyngeal Reflux. Completed, enrolled 20 participants.

Detailed Summary

It is postulated that the incompetence of the upper esophageal sphincter (UES) to restrict passage of esophageal refluxate is fundamental to the development of LPR. The UES Assist Device (UESAD) is a novel device that applies relatively modest external cricoid pressure, which results in a 20 to 30 mmHg intraluminal UES pressure increase. Pepsin, a proteolytic enzyme produced in the stomach, has been detected in the laryngeal epithelium of patients with reflux associated laryngeal symptoms and implicated in the pathogenesis of laryngopharyngeal reflux. This study will assess the effectiveness of a UESAD worn for 2 weeks on LPR symptoms and salivary pepsin levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLaryngopharyngeal Reflux
Countries--
CollaboratorsSomna Therapeutics, L.L.C.

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 17, 2015
Enrollment StartSep 1, 2015
Primary CompletionAug 31, 2017
Study CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.8 years ago

Interventions

UESADdevice

Device designed to provide modest cricoid pressure to reduce reflux