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

June 22, 2026 updated by: Gerd Care Medical Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 occurrence and severity of GERD-related symptoms using the eGERD smartphone application.

GERD-HRQL questionnaire are filled at the onset (Day 1) and at the end (Day 14) of this phase. Questionnaire score obtained at the end of the washout phase (QoL Score baseline) are regarded as baseline for the QoL secondary endpoint.

On the last day of the washout phase (Day 14), a 24h wireless pH monitoring test (Bravo) is initiated, in order to obtain acid exposure time (AET) and DeMeester score (DM) baseline levels.

The device treatment phase consists of continuous usage of the study device for 28 days.

At the onset of the device treatment phase, the pH monitoring data is downloaded and analyzed, to establish AET and DM baseline levels. To be eligible for randomization and study device usage, a participant must have (i) at least 18 hours of baseline monitoring data , and (ii) abnormal baseline AET (above 6%). Ineligible subjects are classified as screen failures. participants with insufficient baseline monitoring data (less than 18 monitoring hours) are offered to extend the baseline monitoring for another 24 hours.

Upon establishing participant eligibility and performing randomization, a new 96h wireless pH monitoring test is initiated using the same Bravo capsule already in place. At the same time, the participant starts using the study device. One day later, a short clinic visit is held in which proper operation of the study device is verified. At the end of the 96h pH monitoring test, the monitoring system is collected and the data downloaded.

Usage of the study device is continued from randomization for 28 days. Esophageal acid exposure time (AET) and DeMeester score (DM) obtained from the 24h wireless pH monitoring test are regarded as baseline for AET primary endpoint and DeMeester score secondary endpoint, respectively.

Esophageal acid exposure time and DeMeester score obtained from the last Complete Monitoring Day of the 96h monitoring test are considered AET primary endpoint and DeMeester score secondary endpoint, respectively.

Throughout this phase, participants are using a study device (either functional or sham), after receiving instructions on its usage. Participants are instructed to use the study device 24 hours per day, 7 days per week (excluding device charging, bathing, sporting, private situations, etc.).

Usage of antacids (Gaviscon Regular Strength antacid tablets, 2-4 tablets, up to 4 times a day) as a rescue treatment is allowed after the Bravo system has been collected from the participant (Day 19). Rescue treatment usage is reported and recorded. Usage of any other type of GERD-treatment is prohibited throughout the entire phase.

GERD-HRQL questionnaire is filled at the end of this phase (or on end-of-study visit, in case of early termination). Resulting score is regarded as QoL secondary endpoint.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Recruiting
        • Gastroenterology department, Emek medical center (EMC)
        • Contact:
        • Principal Investigator:
          • Fahmi Shibli, MD
      • Haifa, Israel
        • Recruiting
        • Gastroenterology department, Rambam Health Care Campus
        • Contact:
        • Principal Investigator:
          • Rita Brun, MD
      • Petah Tikva, Israel
        • Recruiting
        • Gastroenterology department, Rabin medical center (RMC)
        • Contact:
        • Principal Investigator:
          • Ram Dickman, Prof.
      • Tel Aviv, Israel
        • Recruiting
        • Gastroenterology department, Tel Aviv Sourasky Medical Center (Ichilov)
        • Contact:
        • Principal Investigator:
          • Yoav Mazor, MD
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Not yet recruiting
        • Division of Gastroenterology & Hepatology Feinberg School of Medicine Northwestern University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 with written agreement from the Medical Director, to have gastroesophageal reflux disease (GERD) other than functional GERD; or Undergone a catheter-based 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); or, in the absence of such testing, has been determined by the Principal Investigator (PI), based on a detailed anamnesis and with written agreement from the Medical Director, to have gastroesophageal reflux disease (GERD) other than functional GERD.
  4. Able and willing to give informed consent for participation in the study and to comply with all study requirements, including operating the smartphone application.
  5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

  1. Previously undergoing gastric or esophageal surgery
  2. Active peptic ulcer disease or symptomatic helicobacter
  3. Esophageal or gastric varices or esophageal peptic stricture
  4. Severe dysphagia
  5. History of suspected or confirmed esophageal or gastric cancer
  6. History of any other malignancy in the last 2 years
  7. Pregnant women or women intending to become pregnant during the trial period
  8. Uncontrolled diabetes mellitus, defined as HbA1c > 7.5%
  9. Severe cardiac conditions such as cardiac arrhythmia or ischemia or cardiac pacemaker / defibrillator
  10. Having any implanted electrical device (e.g. sacral nerve stimulation, brain stimulator, others)
  11. Known allergy to the device's adhesives/patches
  12. Severe pulmonary diseases
  13. History of significant multisystem diseases (e.g. kidney failure, liver failure)
  14. Known autoimmune or a connective tissue disorder (e.g. scleroderma, CREST-syndrome, Sjogren's Syndrome), requiring therapy in the preceding 2 years
  15. History of Barrett's esophagus
  16. Para-esophageal hiatal hernia
  17. Known history of sliding hiatal hernia ≥4 cm in the last 3 years
  18. Known history of erosive esophagitis Grade C or D (LA classification) in the past 5 years
  19. Obesity, defined as BMI>32
  20. History of gastroparesis
  21. History of fibromyalgia, epilepsy, endometriosis
  22. Umbilical hernia >3cm
  23. Past usage experience with the study device
  24. Those currently enrolled in any other interventional clinical study
  25. Inability to sign the informed consent
  26. Inability to understand and fill the reports and questionnaires included in the study
  27. Inability to follow the study requisites
  28. Other medical conditions/medications that would interfere with subject safety or data collection in the opinion of the PI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Participants in the active arm will be using a functional version of the investigational device for 28 days.
Device: 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.
Sham Comparator: Control
Participants in the control arm will be using a sham version of the investigational device for 28 days.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and severity of Adverse Device Effects (ADEs)
Time Frame: From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Number and severity of Adverse Device Effects (ADEs) occurring when using the investigational device.
From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Change in esophageal acid exposure time
Time Frame: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Magnitude of change (from baseline to within normal limits) of acid exposure time (AET), as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage of rescue treatment
Time Frame: From the end of the pH monitoring test (Day 19) to the end of the device treatment phase (Day 42)
The daily number of reported rescue treatment events, averaged over the period allowed for rescue treatment
From the end of the pH monitoring test (Day 19) to the end of the device treatment phase (Day 42)
Number of subjects electing to withdraw their consent
Time Frame: From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Number of subjects electing to withdraw their consent during the device treatment phase
From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Quality of life improvement
Time Frame: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Magnitude of change (from baseline) of the total score obtained in GERD-HRQL (GERD Health-Related Quality of Life) questionnaire.
End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Change in DeMeester Score
Time Frame: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Magnitude of change (from baseline to within normal limits) of DeMeester score, as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Change in the frequency of regurgitation events
Time Frame: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Magnitude of change in the frequency of regurgitation events reported by patients using the smartphone application, when averaged over the last week of the device treatment phase, compared to the last week of the washout phase
End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Change in the frequency of heartburn events
Time Frame: End of the washout phase (Day 14) and end of the device treatment phase (Day 42)
Magnitude of change in the frequency of heartburn events reported by patients using the smartphone application, when averaged over the last week of the device treatment phase, compared to the last week of the washout phase
End of the washout phase (Day 14) and end of the device treatment phase (Day 42)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in esophageal acid exposure time (absolute)
Time Frame: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Magnitude of absolute change (from baseline) of acid exposure time (AET), as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Change in DeMeester Score (absolute)
Time Frame: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
Magnitude of absolute change (from baseline) of DeMeester score, as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerd Care Medical Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-PRO-0300
  • MOH_2024-05-12_013278 (Registry Identifier: MyTrial (Israel Ministry of Health Clinical Trial Registry))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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