What this Trial Is About

Gastroesophageal Reflux Disease (GERD) affects a significant portion of the population and can cause bothersome symptoms and complications. Current diagnostic tests, including upper gastrointestinal endoscopy and 24-hour impedance-pH monitoring, have limitations such as low sensitivity or patient discomfort. This research aims to evaluate a new mucosal impedance measurement technology that may better diagnose GERD, especially in patients with non-erosive reflux disease (NERD), during the initial endoscopy performed under sedation. Participants will undergo a 4-week screening period with proton pump inhibitor (PPI) washout before receiving an upper gastrointestinal endoscopy with mucosal impedance measurement using the MiVu™ Mucosal Integrity Testing System. This device attaches to the endoscope and measures esophageal mucosal integrity at multiple sites. Following this, patients will also have a 24-hour impedance/pH monitoring without PPI treatment. Based on acid exposure measurements, patients will be classified into NERD or non-NERD groups and receive tailored treatment with either dexlansoprazole or amitriptyline. During the study, researchers will collect data on mucosal impedance patterns and diagnostic performance immediately after procedures. Participants will be assessed using questionnaires such as the GERDq and GerdQ before and after treatment. The study aims to enroll 120 patients aged 18 to 65 years who have GERD symptoms not responding to PPI therapy and no erosive esophagitis. The total study involvement includes baseline measurements, diagnostic procedures, treatment, and an 8-week follow-up assessment.

Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease