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

Conditions

• GERD (Gastroesophageal Reflux Disease)

Eligibility Criteria

Sex

ALL

Age

22 Years - 75 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Sep 15, 2024

Status verified

Jun 2026

Primary completion

Mar 31, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Active
  Participants in the active arm will be using a functional version of the investigational device for 28 days.
• Sham Comparator: Control
  Participants in the control arm will be using a sham version of the investigational device for 28 days.

Primary Outcome Measure

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 ]

Locations (1)

Find similar trials in Chicago, IL

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