NCT02749071

An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: EndoStim Inc. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The purpose of this investigation is to demonstrate the safety and effectiveness of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System in the treatment of subjects with gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled clinical investigation. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for a 6-month, double-blind phase followed by an additional open-label treatment phase in which all subjects will receive electrical stimulation therapy for a total of 12 months. Subjects continue on stimulation treatment and an extended open-label follow-up phase includes an 18 month post-stimulation phone interview followed by annual visits through 5 years post-stimulation.

Conditions

• Gastroesophageal Reflux Disease (GERD)
• Reflux, Gastroesophageal
• Gastroesophageal Reflux
• Acid Reflux

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic implantation surgery	Laparoscopic surgery to implant the pulse generator and bipolar lead.
DEVICE	EndoStim stimulation for first six months of study	Lower esophageal stimulation
DEVICE	EndoStim stimulation from Month 6 thru end of study	Lower esophageal stimulation
DEVICE	Sham EndoStim stimulation for first six months of study	EndoStim device remains "off" (no stimulation delivered)

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-04-22
• Last updated: 2019-10-18

Locations

21 sites across 4 countries: United States, Belgium, Netherlands, United Kingdom