NCT02552966

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

September 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 26, 2020

Completed
Last Updated

February 26, 2020

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

September 16, 2015

Results QC Date

June 11, 2019

Last Update Submit

February 24, 2020

Conditions

Laryngopharyngeal Reflux

Outcome Measures

Primary Outcomes (1)

  • Salivary Pepsin Concentration

    Average salivary pepsin concentration

    2 weeks

Secondary Outcomes (3)

  • RSI Score

    2 weeks

  • GerdQ Score

    2 weeks

  • NGSSIQ Score

    2 weeks

Study Arms (1)

UESAD

EXPERIMENTAL

Upper Esophageal Sphincter Assist Device

Device: UESAD

Interventions

UESADDEVICE

Device designed to provide modest cricoid pressure to reduce reflux

UESAD

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female persons age 18-90
  • Patients with LPR symptoms (RSI \>13)

You may not qualify if:

  • Pregnant patients per history on initial evaluation.
  • Adults unable to consent in English
  • Patients who are currently imprisoned
  • Patients started on PPI therapy within 4 weeks of study
  • Patients with implants or implant parts that reside in the area where the REZA BAND is applied.
  • Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
  • Patients diagnosed with glaucoma.
  • Patients who had a malignancy of the neck, including neck surgery.
  • Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
  • Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
  • Patients who use nocturnal NIV machines such as CPAP or BiPAP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • El-Serag HB, Lee P, Buchner A, Inadomi JM, Gavin M, McCarthy DM. Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial. Am J Gastroenterol. 2001 Apr;96(4):979-83. doi: 10.1111/j.1572-0241.2001.03681.x.

    PMID: 11316215BACKGROUND

  • Francis DO, Rymer JA, Slaughter JC, Choksi Y, Jiramongkolchai P, Ogbeide E, Tran C, Goutte M, Garrett CG, Hagaman D, Vaezi MF. High economic burden of caring for patients with suspected extraesophageal reflux. Am J Gastroenterol. 2013 Jun;108(6):905-11. doi: 10.1038/ajg.2013.69. Epub 2013 Apr 2.

    PMID: 23545710BACKGROUND

  • Yadlapati R, Craft J, Adkins CJ, Pandolfino JE. The Upper Esophageal Sphincter Assist Device Is Associated With Symptom Response in Reflux-Associated Laryngeal Symptoms. Clin Gastroenterol Hepatol. 2018 Oct;16(10):1670-1672. doi: 10.1016/j.cgh.2018.01.031. Epub 2018 Jan 31.

    PMID: 29408585DERIVED

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
Dr. John Pandolfino, Principal Investigator
Organization
Northwestern University
j-pandolfino@northwestern.edu
3126950182

Study Officials

  • John E Pandolfino, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 17, 2015

Study Start

September 1, 2015

Primary Completion

August 31, 2017

Study Completion

August 31, 2018

Last Updated

February 26, 2020

Results First Posted

February 26, 2020

Record last verified: 2019-07