Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
All Genders
NCT06613438

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

Led by Gerd Care Medical Ltd · Updated on 2026-04-15

84

Participants Needed

4

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 22Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 22 to 75 years
  • Has experienced at least three heartburn or regurgitation episodes per week during the past three months
  • Has had a wireless or catheter-based pH monitoring test in the past 24 months showing acid exposure time of 6% or more on at least 2 days, or has been diagnosed with GERD by the Principal Investigator
  • Able and willing to give informed consent and comply with study requirements, including using the smartphone app
  • Willing to allow their General Practitioner and consultant to be informed of study participation
Not Eligible

You will not qualify if you...

  • Previous gastric or esophageal surgery
  • Active peptic ulcer disease or symptomatic helicobacter infection
  • Esophageal or gastric varices or esophageal peptic stricture
  • Severe difficulty swallowing (dysphagia)
  • History of esophageal or gastric cancer
  • History of any other cancer within the last 2 years
  • Pregnant women or women planning pregnancy during the trial
  • Uncontrolled diabetes with HbA1c above 7.5%
  • Severe heart conditions, including arrhythmia, ischemia, or having a pacemaker/defibrillator
  • Having any implanted electrical device
  • Known allergy to device adhesives or patches
  • Severe lung diseases
  • History of serious multisystem diseases such as kidney or liver failure
  • Known autoimmune or connective tissue disorders requiring recent therapy
  • History of Barrett's esophagus
  • Para-esophageal hiatal hernia
  • Sliding hiatal hernia larger than 4 cm in the last 3 years
  • Erosive esophagitis Grade C or D in the past 5 years
  • Obesity with BMI over 32
  • History of gastroparesis
  • History of fibromyalgia, epilepsy, or endometriosis
  • Umbilical hernia larger than 3 cm
  • Previous use of the study device
  • Current participation in another interventional clinical study
  • Unable to sign informed consent
  • Unable to understand or complete study reports and questionnaires
  • Unable to follow study requirements
  • Other medical conditions or medications that might affect safety or data collection as decided by the Principal Investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Gastroenterology department, Emek medical center (EMC)

Afula, Israel

Actively Recruiting

2

Gastroenterology department, Rambam Health Care Campus

Haifa, Israel

Actively Recruiting

3

Gastroenterology department, Rabin medical center (RMC)

Petah Tikva, Israel

Actively Recruiting

4

Gastroenterology department, Tel Aviv Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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