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NCT00229086 Clinical Trial

Gatekeeper European 005

GERD Clinical Trial

Official title:
Long Term Follow-up European Gatekeeper Study 005

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00229086
Other study ID # MGU-004
Secondary ID
Status Terminated
Phase N/A
First received September 27, 2005
Last updated July 24, 2008

Study information
Verified date July 2008
Source MedtronicNeuro
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 55
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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

N/A

Related Conditions & MeSH terms

Intervention

Device:
• Gatekeeper Reflux Repari System (Device)

Locations
Country Name City State
Switzerland Contact Medtronic for specific location Tolochenaz
United States Contact Medtronic for specific site information Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Switzerland, 

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