Overview

This trial is active, not recruiting.

Conditions gastroesophageal reflux disease (gerd), non-erosive reflux disease (nerd)
Treatment standard of care esophagogastroduodenoscopy (egd) with mucosal impedance testing
Sponsor Vanderbilt University
Start date July 2013
End date April 2016
Trial size 40 participants
Trial identifier NCT02318862, 130084

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(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
standard of care esophagogastroduodenoscopy (egd) with mucosal impedance testing
(Other)
Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing
standard of care esophagogastroduodenoscopy (egd) with mucosal impedance testing

Primary Outcomes

Measure
Measurement of lower esophageal impedance using mucosal impedance catheter
time frame: During standard of care EGD

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Assessment of Esophageal Epithelium Integrity With Mucosal Impedance
Principal investigator Michael Vaezi, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.