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Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms
Sponsor: 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.
Official title: The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD)
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2024-09-15
Completion Date
2026-04
Last Updated
2025-09-03
Healthy Volunteers
No
Conditions
Interventions
eGERD 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.
eGERD_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 (3)
Gastroenterology department, Emek medical center (EMC)
Afula, Israel
Gastroenterology department, Rambam Health Care Campus
Haifa, Israel
Gastroenterology department, Rabin medical center (RMC)
Petah Tikva, Israel