NCT06613438 Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 84 participants in total. It began in 2024-09-15 with a primary completion date of 2027-03.

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.

Eligibility 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

Frequently Asked Questions

Related Trials