Gatekeeper European 005

This study has been terminated.
Information provided by:
MedtronicNeuro Identifier:
First received: September 27, 2005
Last updated: July 24, 2008
Last verified: July 2008

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
Device: Gatekeeper Reflux Repari System (Device)

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

Resource links provided by NLM:

Further study details as provided by MedtronicNeuro:

Estimated Enrollment: 55

Genders Eligible for Study:   Both

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
Please refer to this study by its identifier: NCT00229086

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

No publications provided Identifier: NCT00229086     History of Changes
Other Study ID Numbers: MGU-004
Study First Received: September 27, 2005
Last Updated: July 24, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics processed this record on April 16, 2014