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

NCT ID: NCT06613438

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2026-04-30

Brief 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.

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.

Conditions

GERD (Gastroesophageal Reflux Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

Participants in the active arm will be using a functional version of the investigational device for 28 days.

Group Type: EXPERIMENTAL

eGERD device

Intervention Type: 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.

Control

Participants in the control arm will be using a sham version of the investigational device for 28 days.

Group Type: SHAM_COMPARATOR

eGERD_Sham

Intervention Type: DEVICE

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.

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 22 - 75
• Has been typically suffering from at least three heartburn and/or regurgitation episodes per week during the past three months.
• 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 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).
• Able and willing to give informed consent for participation in the study and to comply with all study requirements, including operating the smartphone application.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gerd Care Medical Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastroenterology department, Emek medical center (EMC)

Afula, , Israel

Site Status: RECRUITING

Gastroenterology department, Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Gastroenterology department, Rabin medical center (RMC)

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Fahmi Shibli, MD

Role: primary

fahmi_sh@clalit.org.il

972544508118

Rita Brun, MD

Role: primary

r_brun@rambam.health.gov.il

972502061142

Ram Dickman, Prof.

Role: primary

dickmanr@clalit.org.il

972523428692

Related Links

https://www.gerd-care.com/join-our-clinical-study

Related Info

Other Identifiers

MOH_2024-05-12_013278

Identifier Type: REGISTRY

Identifier Source: secondary_id

CL-PRO-0300

Identifier Type: -

Identifier Source: org_study_id