Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms (NCT06613438) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms
United States, Israel84 participantsStarted 2024-09-15
Plain-language 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.
Who can participate
Age range
22 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and severity of Adverse Device Effects (ADEs)
Timeframe: From the beginning (Day 15) to the end (Day 42) of the device treatment phase
2
Change in esophageal acid exposure time
Timeframe: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
. 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 or symptomatic helicobacter
. 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%