Safety and Effectiveness of eGERD Device to Reduce Gastroesophageal Reflux Disease (GERD) Symptoms

NCT06613438 | Recruiting

• 2 other identifiers: CL-PRO-0300MOH_2024-05-12_013278
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

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:

1. 1.Does the eGERD device reduce acidity in the esophagus?
2. 2.Does the eGERD device reduce GERD symptoms such as heartburn and regurgitation?
3. 3.What medical problems do participants have when using the eGERD device?

Conditions

GERD (Gastroesophageal Reflux Disease)

Keywords

Electrostimulation; Refulx; Regurgitation; eGERD

Outcome Measures

Primary Outcomes (2)

• Number and severity of Adverse Device Effects (ADEs)

  Number and severity of Adverse Device Effects (ADEs) occurring when using the investigational device.

  From the beginning (Day 15) to the end (Day 42) of the device treatment phase

• 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.

  First pH monitoring day (Day 15) and last pH monitoring day (Day 19)

Secondary Outcomes (6)

• Change in DeMeester Score

  First pH monitoring day (Day 15) and last pH monitoring day (Day 19)

• Quality of life improvement

  End of the washout phase (Day 14) and end of the device treatment phase (Day 42)

• 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)

• Usage of rescue treatment

  From the end of the pH monitoring test (Day 19) to the end of the device treatment phase (Day 42)

Other Outcomes (2)

• Change in esophageal acid exposure time (absolute)

  First pH monitoring day (Day 15) and last pH monitoring day (Day 19)

• Change in DeMeester Score (absolute)

  First pH monitoring day (Day 15) and last pH monitoring day (Day 19)

Study Arms (2)

Active

EXPERIMENTAL

Participants in the active arm will be using a functional version of the investigational device for 28 days.

Device: eGERD device

Control

SHAM COMPARATOR

Participants in the control arm will be using a sham version of the investigational device for 28 days.

Device: eGERD_Sham

Interventions

eGERD device DEVICE

The 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.

Active

eGERD_Sham DEVICE

The 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.

Control

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.) 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.

You may not qualify 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
• 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

Sponsors & Collaborators

• Gerd Care Medical Ltd: lead

Study Sites (4)

Gastroenterology department, Emek medical center (EMC)

Afula, Israel

RECRUITING

Gastroenterology department, Rambam Health Care Campus

Haifa, Israel

RECRUITING

Gastroenterology department, Rabin medical center (RMC)

Petah Tikva, Israel

RECRUITING

Gastroenterology department, Tel Aviv Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 26, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)