RecruitingNot ApplicableNCT06613438

Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms

The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD)

Sponsor

Gerd Care Medical Ltd

Enrollment

84 participants

Start Date

Sep 15, 2024

Study Type

INTERVENTIONAL

Conditions

GERD (Gastroesophageal Reflux Disease)

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.

Eligibility

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying eGERD device and a medical device called eGERD_Sham for people with gerd (gastroesophageal reflux disease). The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 University

Chicago, Illinois, United States

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

Gastroenterology department, Tel Aviv Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

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NCT06613438

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