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Tests treatment safety and results for GERD (Gastroesophageal Reflux Disease)
Official title Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms
ClinicalTrials.gov ID: NCT06613438
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- 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.)...
- Able and willing to give informed consent for participation in the study and to comply with all study requirements, including operating the...
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Afula, Israel
- Haifa, Israel
- Petah Tikva, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Afula, Israel; Haifa, Israel; Petah Tikva, Israel; Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.