Using the eGERD device to treat GERD symptoms
The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD)
NA · Gerd Care Medical Ltd · NCT06613438
This study is testing a new device called eGERD to see if it can help people with GERD feel better by reducing their symptoms and improving esophageal acidity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Gerd Care Medical Ltd (industry) |
| Locations | 4 sites (Afula and 3 other locations) |
| Trial ID | NCT06613438 on ClinicalTrials.gov |
What this trial studies
This research evaluates the safety and effectiveness of the eGERD device, designed to treat Gastroesophageal Reflux Disease (GERD). Participants will undergo a 14-day washout phase without GERD medications, followed by a 28-day treatment phase using the eGERD device. The study will assess the device's impact on esophageal acidity and GERD symptoms, with participants reporting their experiences through a smartphone application. A comparison will be made between the active eGERD device and a sham device to determine its effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 75 who experience frequent heartburn or regurgitation episodes.
Not a fit: Patients who have not experienced GERD symptoms or have undergone previous treatments that have resolved their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce GERD symptoms like heartburn and regurgitation for patients.
How similar studies have performed: While the approach of using electrostimulation for GERD is relatively novel, similar studies have shown promise in treating reflux symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Afula and 3 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GERD, Electrostimulation, Refulx, Regurgitation, eGERD