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

July 10, 2009 updated by: MedtronicNeuro

Gatekeeper® System Sham-Controlled Study for the Treatment of GERD

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Contact Medtronic for specific site information
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Contact Medtronic for specific site information
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Contact Medtronic for specific site information
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Contact Medtronic for specific site information
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Contact Medtronic for specific site information
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Contact Medtronic for specific site information
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Contact Medtronic for specific site information
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Contact Medtronic for specific site information
    • New York
      • New York, New York, United States, 10021
        • Contact Medtronic for specific site information
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Contact Medtronic for specific site information
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Contact Medtronic for specific site information

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Gatekeeper

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in serious device and procedure related adverse device effects.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in espophageal pH
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Principal Investigator: Glen Lehman, Indiana University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 13, 2009

Last Update Submitted That Met QC Criteria

July 10, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGU - 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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