Status:
TERMINATED
Gatekeeper European 005
Lead Sponsor:
MedtronicNeuro
Conditions:
GERD
Eligibility:
All Genders
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00229086
Last Update
July 28 2008
Active Locations (2)
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1
Contact Medtronic for specific site information
Minneapolis, Minnesota, United States, 44126
2
Contact Medtronic for specific location
Tolochenaz, Switzerland