Gatekeeper European 005

Medtronic

Status: Terminated

Conditions: GERD

Treatments: Device: Gatekeeper Reflux Repari System (Device)

Study type: Observational

Funder types: Industry

Identifiers

NCT00229086

MGU-004

Details and patient eligibility

About

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

Sex: All

Volunteers: No Healthy Volunteers

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