Gatekeeper European 005

This study has been terminated.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00229086
First received: September 27, 2005
Last updated: July 24, 2008
Last verified: July 2008
  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

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Estimated Enrollment: 55
  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 29, 2014