Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorGerd Care Medical Ltd
About this trial
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
Qualifiers
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.
Able and willing to give informed consent for participation in the study and to comply with all study requirements, including operating the smartphone application.
Disqualifiers
Previously undergoing gastric or esophageal surgery
Active peptic ulcer disease or symptomatic helicobacter
Esophageal or gastric varices or esophageal peptic stricture
Severe dysphagia
Trial design
Treatments tested in this trial
- eGERD device
- eGERD_Sham
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov