Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

NCT02318862 | Completed DMC

• 1 other identifier: 130084
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease (GERD); Non-erosive Reflux Disease (NERD)

Keywords

reflux; GERD; EGD; pH testing

Outcome Measures

Primary Outcomes (1)

• Measurement of lower esophageal impedance using mucosal impedance catheter

  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

Study Arms (2)

GERD

OTHER

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

non-GERD

OTHER

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

Interventions

Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing PROCEDURE

GERD; non-GERD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Non-Erosive Reflux Disease

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michael Vaezi, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: December 17, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)