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

Launched by GERD CARE MEDICAL LTD · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new device called the eGERD device, which aims to help people suffering from Gastroesophageal Reflux Disease (GERD). GERD often causes uncomfortable symptoms like heartburn and regurgitation, where stomach acid comes back up into the throat. The researchers want to find out if the eGERD device can help reduce the acidity in the esophagus (the tube that connects your throat to your stomach) and decrease these GERD symptoms. Participants will use a smartphone app to report their symptoms, and a small capsule will be placed in their esophagus for a few days to measure acidity levels.

To participate in this trial, individuals need to be between 22 and 75 years old and have experienced heartburn or regurgitation at least three times a week over the past three months. They must also be willing to follow the study's requirements, including using the smartphone app. Participants will be divided into two groups: one will receive the actual eGERD device, while the other will receive a look-alike device that does not have any therapeutic effect. This comparison will help researchers determine if the eGERD device is truly effective. If you're interested in joining the study, make sure to talk to your doctor for more details!

Gender

ALL

Eligibility criteria

• 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 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).
• • 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
• • 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