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Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease

NCT01578642 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-02-12

No results posted yet for this study

Summary

The EndoStim Stimulation System is an investigational device intended to improve the lower esophageal sphincter (LES) resting tone and restore LES function in individuals suffering with 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.

Sponsors & Collaborators

  • EndoStim Inc.

    lead INDUSTRY

Principal Investigators

  • Leonardo RODRIGUEZ, M.D · INDISA Clínica da Familia, Santiago, Chile

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Chile

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 NCT01578642 on ClinicalTrials.gov