An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)

This study has been terminated.

( Lack of efficacy )

First Received: September 12, 2005 Last Updated: December 20, 2007 History of Changes

Sponsored by:	MedtronicNeuro
Information provided by:	MedtronicNeuro
ClinicalTrials.gov Identifier:	NCT00200044

Purpose

The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease.

Condition	Intervention
Gastroesophageal Reflux Disease	Device: Gatekeeper Reflux

MedlinePlus related topics: GERD

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Gatekeeper® System Sham-Controlled Study for the Treatment of GERD

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:

- Reduction in serious device and procedure related adverse device effects. [ Time Frame: 6 months ]

Secondary Outcome Measures:

- Improvement in espophageal pH [ Time Frame: 6 months ]

Enrollment:	143
Study Start Date:	December 2002
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Detailed Description:

The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Inclusion: Typical symptoms of GERD with symptomatic improvement on PPIs;
Exclusion: extensive Barrett's esophagus, esophagitis LA Classification Grades C or D, large hiatal hernia, ineffective esophageal motility, morbid obesity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200044

Locations

United States, California
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San Francisco, California, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Kentucky
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Lexington, Kentucky, United States
United States, Missouri
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St.Louis, Missouri, United States
United States, New Hampshire
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Lebanon, New Hampshire, United States
United States, New York
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New York, New York, United States
United States, Tennessee
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Knoxville, Tennessee, United States
United States, Wisconsin
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Milwaukee, Wisconsin, United States
Netherlands
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Amsterdam, Netherlands

Sponsors and Collaborators

MedtronicNeuro

Investigators

Principal Investigator:

Glen Lehman

Indiana University Hospital

More Information

No publications provided

Study ID Numbers:	MGU - 002
Study First Received:	September 12, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00200044 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:

GERD

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on May 07, 2009