An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)

Not Applicable

Terminated

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Device: Gatekeeper Reflux Repair System

• Registration Number: NCT00200044
• Lead Sponsor: MedtronicNeuro

Brief Summary

The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease.

Detailed Description

The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-06
• Study Completion: 2008-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-10
• Last Update Posted: 2009-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Gatekeeper Reflux Repair System	This arm of the study has the procedure but does not get the Gatekeeper prostheses. The Sham arm has the option to cross-over to the Treatment arm at the 6-month visit.
Treatment	Gatekeeper Reflux Repair System	The treatment arm has the Gatekeeper devices implanted.

Primary Outcome Measures

Name	Time	Method
Reduction in serious device and procedure related adverse device effects.	6 months

Secondary Outcome Measures

Name	Time	Method
Improvement in espophageal pH	6 months

Trial Locations

Locations (1)

Contact Medtronic for specific site information; 🇳🇱 Amsterdam, Netherlands