Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

April 27, 2017 updated by: Michael Vaezi, Vanderbilt University Medical Center
Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive Mucosal Impedance technique for more accurate detection of GERD while reducing costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO
  • Previous diagnosis of reflux
  • At least 18 years of age

Exclusion Criteria:

  • Those less than 18 years of age
  • Unable to give informed consent
  • Use of acid suppressive therapy within the last 10 days
  • Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: GERD
Those who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
OTHER: non-GERD
Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of lower esophageal impedance using mucosal impedance catheter
Time Frame: During standard of care EGD
Mucosal impedance is obtained during routine care EGD and readings are compared to 48-hour Bravo capsule results. Mucosal impedance only takes one minute to perform during endoscopy.
During standard of care EGD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

December 11, 2014

First Posted (ESTIMATE)

December 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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