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

Not Applicable
Terminated
Conditions
Gastroesophageal Reflux Disease
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

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
Primary Outcome Measures
NameTimeMethod
Reduction in serious device and procedure related adverse device effects.6 months
Secondary Outcome Measures
NameTimeMethod
Improvement in espophageal pH6 months

Trial Locations

Locations (1)

Contact Medtronic for specific site information

🇳🇱

Amsterdam, Netherlands

Contact Medtronic for specific site information
🇳🇱Amsterdam, Netherlands

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