Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device

The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastro Esophageal Reflux
• Intervention / Treatment: Diagnostic test: single catheter mucosal impedance testing; Diagnostic test: balloon assembly mucosal impedance testing

Detailed Description

During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.

Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center Endoscopy Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled for endoscopic procedures (esophagogastroduodenoscopy (EGD)) by the principal investigator as part of their routine care and who do not meet any of the pre-defined exclusion criteria will be considered for participation in the study.

Description

Inclusion Criteria:

• Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement

Exclusion Criteria:

• Age less than 18 years old
• Patients unable to give informed consent
• Use of acid suppressive therapy within last 10 days
• Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GERD patients; Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement and have been diagnosed with GERD will have mucosal impedance measured by single catheter and balloon assembly.	Diagnostic test: single catheter mucosal impedance testing; Diagnostic test: balloon assembly mucosal impedance testing
control; Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement will have mucosal impedance measured by single catheter and balloon assembly.	Diagnostic test: single catheter mucosal impedance testing; Diagnostic test: balloon assembly mucosal impedance testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mucosal impedance values	compare the mucosal impedance values obtained from single channel catheter and balloon assembly catheter in GERD patients and controls	Values will be obtained at conclusion of EGD, an expected average of 6 minutes

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Sandhill Scientific
• Investigators: Principal Investigator: Michael Vaezi, MD, PhD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Patel DA, Higginbotham T, Slaughter JC, Aslam M, Yuksel E, Katzka D, Gyawali CP, Mashi M, Pandolfino J, Vaezi MF. Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders. Gastroenterology. 2019 May;156(6):1617-1626.e1. doi: 10.1053/j.gastro.2019.01.253. Epub 2019 Jan 31.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2014
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: 140470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No