The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD)
Gerd Care Medical Ltd
Summary
The purpose of this research is to evaluate the safety and effectiveness of the eGERD device, which is a novel device for treating Gastroesophageal Reflux Disease (GERD). The main questions this research aims to answer are: 1. Does the eGERD device reduce acidity in the esophagus? 2. Does the eGERD device reduce GERD symptoms such as heartburn and regurgitation? 3. What medical problems do participants have when using the eGERD device? To assess the acidity in the esophagus, a wireless standard-of-care capsule called Bravo will be placed in the participants esophagus (throat) for several days. To assess GERD symptoms, participants will be requested to report symptoms they experience using a smartphone application. Researchers will compare a real version of the eGERD device to a sham version (a look-alike device that has no therapeutic effect) to see if the eGERD device is effective in treating GERD.
Description
The study includes two consecutive phases: a 14-day washout phase followed by a 28-day device treatment phase. The washout phase starts on or shortly after the Screening visit, in which the participants sign the informed consent form (ICF) and their eligibility criteria are assessed. The first day of the washout phase is considered Day 1 of the study. In the washout phase, participants are instructed to avoid any GERD-treatment medications (including antacids), either prescribed or over-the-counter (OTC), and to keep their regular daily routines. Participants are also instructed to report o…