Primary diagnostic tools used in practice today for suspected GERD include endoscopy and ambulatory reflux monitoring. These commonly used tools have significant limitations, resulting in many tested patients having a vague, questionable diagnosis that is not an effective guide for therapy. Esophageal mucosal injury detected by endoscopic evaluation is present in less than 30% of patients.i Currently available pH technology only measures the acidity of refluxed material at a single point along the esophagus. Furthermore, these tests fail to account for day-to-day variability of reflux, as they only provide a 24- to 48-hour snapshot of a disease process that is chronic in nature.ii Thus, current diagnostic testing in GERD is suboptimal and can have false-negative rates of nearly 30% in patients that have endoscopic esophagitis.iii iv
i Dent J. Gastro-oesophageal reflux disease. Digestion 1998;59: 433–445.
ii Patel DA, Vaezi MF. Utility of esophageal mucosal impedance as a diagnostic test for esophageal disease. Curr Opin Gastroenterol 2017;33:277–284.
iii Wenner J, Johansson J, Johnsson F, et al. Optimal thresholds and discriminatory power of 48-h wireless esophageal pH monitoring in the diagnosis of GERD. Am J Gastroenterol 2007;102:1862–1869.
iv Kessels SJM, Newton SS, Morona JK, et al. Safety and efficacy of wireless pH monitoring in patients suspected of gastroesophageal reflux disease: a systematic review. J Clin Gastroenterol 2017;51:777–788.
v Caroline Barrett & Yash Choksi & Michael F. Vaezi, Mucosal Impedance: a New Approach to Diagnosing Gastroesophageal Current Gastroenterology Reports (2018) 20:33 Reflux Disease and Eosinophilic Esophagitis.
vi Choksi Y, Lal P, Slaughter JC, et al. Esophageal mucosal impedance patterns discriminate patients with eosinophilic esophagitis from patients with GERD. Clin Gastroenterol Hepatol 2018;16:664–671 e1.
vii Dhyanesh A. Patel, Tina Higginbotham, James C. Slaughter, Muhammad Aslam, Elif Yuksel, David Katzka, C. Prakash Gyawali, Melina Mashi, John Pandolfino, and Michael F. Vaezi, Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders, Gastroenterology 2019;156:1617–1626.
MiVu™ Mucosal Integrity Testing System is covered by one or more of the following patents: US9, 814, 408 and US10, 321, 867.