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84 Participants NeededMy employer runs this trial

eGERD Device for Acid Reflux

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Gerd Care Medical Ltd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults aged 22 to 75 who have had frequent heartburn or acid reflux (at least three times a week) over the past three months and have completed specific esophagus acidity tests in the last two years. Participants must be able to use a smartphone app and agree to study requirements.

Inclusion Criteria

Undergone a catheter-based pH monitoring test during the past 24 months prior to enrollment following a 7-day off-PPI period, with AET ≥6%; or determined by the Principal Investigator with Medical Director agreement to have GERD other than functional GERD
Able and willing to give informed consent and comply with all study requirements including operating the smartphone application
Undergone a wireless (Bravo) pH monitoring test during the past 24 months prior to enrollment following a 7-day off-PPI period, with AET ≥6% in at least 2 monitoring days and averaged over all monitoring days; or determined by the Principal Investigator with Medical Director agreement to have GERD other than functional GERD
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Exclusion Criteria

Past usage experience with the study device
Currently enrolled in any other interventional clinical study
Inability to follow study requisites
See 25 more

What Are the Treatments Tested in This Trial?

Interventions

  • eGERD device

Trial Overview

The study compares the new eGERD device, designed to reduce acid reflux symptoms, with a sham (inactive) device. Participants are randomly assigned to one group and will track their symptoms using an app while researchers monitor changes in esophagus acidity.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gerd Care Medical Ltd

Lead Sponsor

Trials
1
Recruited
80+

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