Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD); Non-erosive Reflux Disease (NERD)
• Interventions: Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

• Registration Number: NCT02318862
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-17
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GERD	Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing	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
non-GERD	Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing	Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing

Primary Outcome Measures

Name	Time	Method
Measurement of lower esophageal impedance using mucosal impedance catheter	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States