NCT06613438 · Gerd Care Medical Ltd
Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms
What this study is about
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.
View original scientific description
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.
Interventions
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.
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.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, 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.
- 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 or symptomatic helicobacter
- 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
Where
- Chicago, Illinois
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations