The Effect of Non-Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 7
- Primary Endpoint
- Number and severity of Adverse Device Effects (ADEs)
Study Overview
Brief 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:
- Does the eGERD device reduce acidity in the esophagus?
- Does the eGERD device reduce GERD symptoms such as heartburn and regurgitation?
- 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.
Detailed Description
The study includes two consecutive phases: a 14-day washout phase followed by a 28-day device treatment phase.
The washout phase starts on or shortly after the Screening visit, in which the participants sign the informed consent form (ICF) and their eligibility criteria are assessed. The first day of the washout phase is considered Day 1 of the study.
In the washout phase, participants are instructed to avoid any GERD-treatment medications (including antacids), either prescribed or over-the-counter (OTC), and to keep their regular daily routines.
Participants are also instructed to report occurrence and severity of GERD-related symptoms using the eGERD smartphone application.
GERD-HRQL questionnaire are filled at the onset (Day 1) and at the end (Day 14) of this phase. Questionnaire score obtained at the end of the washout phase (QoL Score baseline) are regarded as baseline for the QoL secondary endpoint.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 22 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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%
- •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
Arms & Interventions
Control
Participants in the control arm will be using a sham version of the investigational device for 28 days.
Intervention: eGERD_Sham (Device)
Active
Participants in the active arm will be using a functional version of the investigational device for 28 days.
Intervention: eGERD device (Device)
Outcomes
Primary Outcomes
Number and severity of Adverse Device Effects (ADEs)
Time Frame: From the beginning (Day 15) to the end (Day 42) of the device treatment phase
Number and severity of Adverse Device Effects (ADEs) occurring when using the investigational device.
Change in esophageal acid exposure time
Time Frame: First pH monitoring day (Day 15) and last pH monitoring day (Day 19)
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.
Secondary Outcomes
- Usage of rescue treatment(From the end of the pH monitoring test (Day 19) to the end of the device treatment phase (Day 42))
- Number of subjects electing to withdraw their consent(From the beginning (Day 15) to the end (Day 42) of the device treatment phase)
- Quality of life improvement(End of the washout phase (Day 14) and end of the device treatment phase (Day 42))
- Change in DeMeester Score(First pH monitoring day (Day 15) and last pH monitoring day (Day 19))
- Change in the frequency of regurgitation events(End of the washout phase (Day 14) and end of the device treatment phase (Day 42))
- Change in the frequency of heartburn events(End of the washout phase (Day 14) and end of the device treatment phase (Day 42))