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Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD

NCT01574339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-14

No results posted yet for this study

Summary

The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DEVICE

EndoStim LES Stimulation System

The EndoStim LES Stimulation System comprises three components: an electrical stimulation lead, an implantable pulse generator (IPG) and an external programmer. The IPG and stimulation lead are to be implanted within the subject's body using conventional laparoscopy. The device programmer is to be used by the study investigator and/or a technical representative.

Sponsors & Collaborators

  • EndoStim Inc.

    lead INDUSTRY

Principal Investigators

  • A. J. Bredenoord, Dr. med. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • T. Horbach, PD. Dr. med. · Stadtkrankenhaus Schwabach, Schwabach, Germany

  • A. Escalona, Dr. med. · Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago, Chile

  • Nageshwar Reddy, M.D., · Asian Institute of Gastroenterology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Chile
  • Colombia
  • Hong Kong
  • India
  • Mexico
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

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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 NCT01574339 on ClinicalTrials.gov