Diagnostic Utility of Mucosal Impedance Device in Patients With GERD and Chronic Esophageal Disorders:

Diagnostic Utility of Mucosal Impedance Device in participants with GERD and chronic esophageal disorders:

Background & Significance Chronic benign esophageal disorders such as Gastroesophageal reflux disease (GERD) and eosinophilic esophagitis are common gastrointestinal disorders affecting nearly 20% and 0.1% of the population, respectively. Although these conditions are frequent, the diagnosis of GERD or EoE requires complex decision making involving endoscopic examination, histopathological examination, and esophageal pH testing. This translates into significant economic burden; For example, burden due to GERD is about $24 billion annually. Additionally, there may be a delay in the diagnosis of GERD or EoE as Investigators might have to do multiple procedures such as upper endoscopy, esophageal pH testing, etc for the same participant for confirmation of the diagnosis. In addition, there could be overlay between GERD and EoE in the diagnosis which make cause delay in the diagnosis and decision making.

In summary, current diagnostic testing for GERD lead to several challenges:

• Delayed diagnosis, particularly in cases where participants undergo normal endoscopy but still experience symptoms.
• Increased healthcare costs, with GERD alone accounting for an estimated $24 billion annually in the United States.
• Diagnostic overlap between GERD and EoE, which complicates clinical decision-making and contributes to further delays or misdiagnoses.

Since majority of the participants who undergo upper endoscopy for GERD, have normal endoscopic visualization of esophagus, esophageal pH impedance or wireless pH testing are essential to make the diagnosis of GERD. Hence, Esophageal Mucosal impedance (Mivu) is a measurement tool that can evaluate if the structure of the esophageal mucosal tissue as a one-stop solution testing. MI is performed using an FDA approved endoscopic tool called "Mucosal Integrity Conductivity Test System" (Diversatek). The Mivu system software uses the collected data to determine if there is evidence of GERD.