Gatekeeper European 005

July 24, 2008 updated by: MedtronicNeuro

Long Term Follow-up European Gatekeeper Study 005

Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

55

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

  • Switzerland
      • Tolochenaz, Switzerland
        • Contact Medtronic for specific location
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 44126
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study
  • Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent

Exclusion Criteria:

  • Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)
  • Developed other medical illness that may cause the subject to be non-compliant
  • Extensive Barrett's Esophagus (>2 cm)
  • Unable or unwilling to cooperate with the study procedures

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?

Collaborators and Investigators

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

Sponsor

MedtronicNeuro

Investigators

  • Principal Investigator: Medtronic GU Investigator, MedtronicNeuro

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 Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 28, 2008

Last Update Submitted That Met QC Criteria

July 24, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • MGU-004

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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