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…
Eligibility
- Age range
- 22–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female, aged 22 - 75 2. Has been typically suffering from at least three heartburn and/or regurgitation episodes per week during the past three months. 3. Undergone a wireless (Bravo) pH monitoring test during the past 24 months prior to enrollment into the current study, following a 7-day (min.) off-PPI period, with AET ≥6% (as defined in section 7.2) in at least 2 monitoring days AND when averaged over all monitoring days of the test; or, in the absence of such testing, has been determined by the Principal Investigator (PI), based on a detailed anamnesis and w…
Interventions
- DeviceeGERD device
The eGERD device is a novel device developed by GerdCare Medical for reducing symptoms of GERD. The device is noninvasive and designed for self-use in the home environment. It is applied on the abdominal skin and generates electrical stimulation pulses. For optimized effect, the stimulation is synchronized with the breathing phase, such that it is active mainly during inhalation. The stimulation intensity can be adjusted by the user.
- DeviceeGERD_Sham
The eGERD\_Sham is a sham version of the eGERD device. It is capable of inducing sensation of electrical stimulation pulses in the target abdominal muscles without a therapeutic effect. Aside from this difference, the eGERD\_Sham is identical to the eGERD device.
Locations (5)
- Division of Gastroenterology & Hepatology Feinberg School of Medicine Northwestern UniversityChicago, Illinois
- Gastroenterology department, Emek medical center (EMC)Afula
- Gastroenterology department, Rambam Health Care CampusHaifa
- Gastroenterology department, Rabin medical center (RMC)Petah Tikva
- Gastroenterology department, Tel Aviv Sourasky Medical Center (Ichilov)Tel Aviv