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

NCT02749071 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2019-10-18

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • EndoStim Inc.

    lead INDUSTRY

Principal Investigators

  • Nicholas J Shaheen, MD, MPH · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • United States
  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02749071 on ClinicalTrials.gov