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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)
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200044
First received: September 12, 2005
Last updated: July 10, 2009
Last verified: July 2009
History of Changes
  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 Repair System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Gatekeeper® System Sham-Controlled Study for the Treatment of GERD

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

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
Study Completion Date: June 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham
This arm of the study has the procedure but does not get the Gatekeeper prostheses. The Sham arm has the option to cross-over to the Treatment arm at the 6-month visit.
 Device: Gatekeeper Reflux Repair System
The Gatekeeper System™ consists of a specialized 16-mm overtube assembly, a 2.4-mm diameter prosthesis delivery system (1-mm diameter needle, dilator, and 2.4-mm diameter sheath), a pushrod assembly and Gatekeeper Prosthesis. Up to 4 prostheses will be implanted at the initial procedure and retreatment with up to four more prostheses will be allowed at 3-months if the subject has a GERD HRQL score >15.
Other Name: Gatekeeper
Active Comparator: Treatment
The treatment arm has the Gatekeeper devices implanted.
 Device: Gatekeeper Reflux Repair System
The Gatekeeper System™ consists of a specialized 16-mm overtube assembly, a 2.4-mm diameter prosthesis delivery system (1-mm diameter needle, dilator, and 2.4-mm diameter sheath), a pushrod assembly and Gatekeeper Prosthesis. Up to 4 prostheses will be implanted at the initial procedure and retreatment with up to four more prostheses will be allowed at 3-months if the subject has a GERD HRQL score >15.
Other Name: Gatekeeper

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
Accepts Healthy Volunteers:   No
Criteria

Diagnosis and main criteria for inclusion:

  • Subjects diagnosed with GERD with symptomatic improvement on PPIs.
  • Subjects who have demonstrated a baseline 24 Hour pH ≥ 4% time with pH ≤ 4.0.
  • Subjects with a baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥ 20 off PPI.

Diagnosis and main criteria for exclusion:

  • Extensive Barrett's Esophagus (> 2 cm).
  • Esophagitis (LA Classification Grades C or D).
  • Previous history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal or gastric cancer.
  • Large hiatal hernia (> 3 cm).
  • Current complaints of clinical dysphagia evidenced by greater than one occurrence per month.
  • Esophageal strictures
  • Esophageal or gastric varices
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200044

Locations
United States, California
Contact Medtronic for specific site information
San Francisco, California, United States, 94115
United States, Georgia
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Atlanta, Georgia, United States, 30322
United States, Illinois
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Chicago, Illinois, United States, 60611
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kentucky
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Lexington, Kentucky, United States, 40536
United States, Missouri
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St. Louis, Missouri, United States, 63110
United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
United States, New York
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New York, New York, United States, 10021
United States, Tennessee
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Knoxville, Tennessee, United States, 37909
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53233
Netherlands
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Amsterdam, Netherlands
Sponsors and Collaborators
MedtronicNeuro
Investigators
Principal Investigator: Glen Lehman Indiana University Hospital
  More Information

No publications provided

Responsible Party: Chad Giese / Clinical Research Specialist, Medtronic Neuromodulation - Gastroenterology and Urology
ClinicalTrials.gov Identifier: NCT00200044     History of Changes
Other Study ID Numbers: MGU - 002
Study First Received: September 12, 2005
Last Updated: July 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013