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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2005

Last Updated Date

July 24, 2008

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00229086 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gatekeeper European 005

Official Title ^ICMJE

Long Term Follow-up European Gatekeeper Study 005

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

GERD

Intervention ^ICMJE

Device: Gatekeeper Reflux Repari System (Device)

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00229086

Other Study ID Numbers ^ICMJE

MGU-004

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

MedtronicNeuro

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Medtronic GU Investigator

MedtronicNeuro

Information Provided By

MedtronicNeuro

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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