Recruiting
Not applicable
Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms
Condition(s) studied
GERD (Gastroesophageal Reflux Disease)
Investigational drug(s) / intervention(s)
eGERD deviceeGERD_Sham
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.
Study 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
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
Primary outcome measure(s)
- Number and severity of Adverse Device Effects (ADEs) — 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 — 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.
Trial sites (5)
| Facility | City | Region | Status |
| Division of Gastroenterology & Hepatology Feinberg School of Medicine Northwestern University |
Chicago |
Illinois |
Not Yet Recruiting |
| Gastroenterology department, Emek medical center (EMC) |
Afula |
Israel |
Recruiting |
| Gastroenterology department, Rambam Health Care Campus |
Haifa |
Israel |
Recruiting |
| Gastroenterology department, Rabin medical center (RMC) |
Petah Tikva |
Israel |
Recruiting |
| Gastroenterology department, Tel Aviv Sourasky Medical Center (Ichilov) |
Tel Aviv |
Israel |
Recruiting |
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