Gatekeeper European 005
Terminated
- Conditions
- GERD
- Registration Number
- NCT00229086
- Lead Sponsor
- MedtronicNeuro
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 55
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Contact Medtronic for specific site information
🇺🇸Minneapolis, Minnesota, United States
Contact Medtronic for specific location
🇨🇭Tolochenaz, Switzerland