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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
eGERD device
DeviceThe eGERD device is a novel device developed by GerdCare Medical for reducing symptoms of GERD. The device is noninvasive and designed for self-use in the home environment. It is applied on the abdominal skin and generates electrical stimulation pulses. For optimized effect, the stimulation is synchronized with the breathing phase, such that it is active mainly during inhalation. The stimulation intensity can be adjusted by the user.
eGERD_Sham
DeviceThe eGERD\_Sham is a sham version of the eGERD device. It is capable of inducing sensation of electrical stimulation pulses in the target abdominal muscles without a therapeutic effect. Aside from this difference, the eGERD\_Sham is identical to the eGERD device.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: ActiveExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number and severity of Adverse Device Effects (ADEs)
Number and severity of Adverse Device Effects (ADEs) occurring when using the investigational device.
Time frame
From the beginning (Day 15) to the end (Day 42) of the device treatment phase2
Change in esophageal acid exposure time
Magnitude of change (from baseline to within normal limits) of acid exposure time (AET), as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
Time frame
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)Secondary outcomes
1
Change in DeMeester Score
Magnitude of change (from baseline to within normal limits) of DeMeester score, as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
Time frame
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)2
Quality of life improvement
Magnitude of change (from baseline) of the total score obtained in GERD-HRQL (GERD Health-Related Quality of Life) questionnaire.
Time frame
End of the washout phase (Day 14) and end of the device treatment phase (Day 42)3
Change in the frequency of regurgitation events
Magnitude of change in the frequency of regurgitation events reported by patients using the smartphone application, when averaged over the last week of the device treatment phase, compared to the last week of the washout phase
Time frame
End of the washout phase (Day 14) and end of the device treatment phase (Day 42)4
Change in the frequency of heartburn events
Magnitude of change in the frequency of heartburn events reported by patients using the smartphone application, when averaged over the last week of the device treatment phase, compared to the last week of the washout phase
Time frame
End of the washout phase (Day 14) and end of the device treatment phase (Day 42)Other outcomes
1
Change in esophageal acid exposure time (absolute)
Magnitude of absolute change (from baseline) of acid exposure time (AET), as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
Time frame
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)2
Change in DeMeester Score (absolute)
Magnitude of absolute change (from baseline) of DeMeester score, as measured in a wireless pH monitoring test (Bravo™) conducted following a 14-day washout phase.
Time frame
First pH monitoring day (Day 15) and last pH monitoring day (Day 19)Sponsors and contacts
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Source ClinicalTrials.gov