Using the eGERD device to treat GERD symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Division of Gastroenterology & Hepatology Feinberg School of Medicine Northwestern University
  Chicago, Illinois, United States Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Quality sleep improvement with evening topical therapy for nocturnal GERD

  This trial tests a medical device given before bed to see if it reduces nighttime GERD symptoms and improves sleep and quality of life in adults with nocturnal reflux.

  Recruiting Cellmedis · Warsaw, Masovian Voivodeship and 1 other locations · NCT07700342

• Gerd symptoms with tegoprazan treatment in adults

  This study tests whether tegoprazan 50 mg (tablet or dispersible tablet) helps GERD symptoms and is safe in adults who meet criteria.

  Recruiting HK inno.N Corporation · Seoul · NCT07678177

• New topical treatment options for GERD symptoms

  This trial tests a medical device to see if it relieves GERD symptoms and improves quality of life in adults compared with a placebo.

  Recruiting Cellmedis · Warsaw, Masovian Voivodeship · NCT07624383

• Left-sided versus traditional bilateral laparoscopic repair for hiatal hernia with reflux

  This compares two laparoscopic operations—a left-sided approach and the traditional bilateral approach—to see which helps adults (18–85) with hiatal hernia whose reflux doesn't get better on usual acid‑reducing medicine.

  Recruiting Beijing Friendship Hospital · Beijing and 1 other locations · NCT07252115

• Improving GERD medication adherence using the GERDCare smartphone app

  This project will test whether the GERDCare smartphone app helps adults with GERD stick to their medications, diet, and lifestyle changes over four weeks.

  Recruiting Institute of Gastroenterology and Hepatology, Vietnam · Hanoi · NCT07125521

• How three ice-cream formulations affect esophageal movement in people with GERD or weak esophageal motility

  This test will try three specially made ice creams to see if they change how the esophagus moves in people with ineffective esophageal motility or GERD.

  Recruiting Federal State Budgetary Scientific Institution · Moscow · NCT07121803

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.