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Gatekeeper European 005

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00229086
First Posted: September 29, 2005
Last Update Posted: July 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MedtronicNeuro
  Purpose
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

Condition Intervention
GERD Device: Gatekeeper Reflux Repari System (Device)

Study Type: Observational
Official Title: Long Term Follow-up European Gatekeeper Study 005

Further study details as provided by MedtronicNeuro:

Estimated Enrollment: 55
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229086


Locations
United States, Minnesota
Contact Medtronic for specific site information
Minneapolis, Minnesota, United States, 44126
Switzerland
Contact Medtronic for specific location
Tolochenaz, Switzerland
Sponsors and Collaborators
MedtronicNeuro
Investigators
Principal Investigator: Medtronic GU Investigator MedtronicNeuro
  More Information

ClinicalTrials.gov Identifier: NCT00229086     History of Changes
Other Study ID Numbers: MGU-004
First Submitted: September 27, 2005
First Posted: September 29, 2005
Last Update Posted: July 28, 2008
Last Verified: July 2008


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