Trial ID or NCT#

NCT02749071

Status

RECRUITING

Purpose

The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.

Official Title

A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Gastroesophageal Reflux Disease (GERD)

Eligibility Criteria

Ages Eligible for Study: 22 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Dr. John Magaña Morton
Bariatric surgeon, General surgeon, Minimally invasive surgeon
Associate Professor of Surgery (General Surgery) at the Stanford University Medical Center
John Clarke, MD
Gastroenterologist, Motility specialist
Clinical Associate Professor, Medicine - Gastroenterology & Hepatology
Kirsten Regalia, MD
Gastroenterologist
Clinical Assistant Professor, Medicine - Gastroenterology & Hepatology

Contact us to find out if this trial is right for you.

CONTACT

Maria Adelus
(650) 721-8436