Status:
TERMINATED
An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
MedtronicNeuro
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- Diagnosis and main criteria for inclusion:
- Subjects diagnosed with GERD with symptomatic improvement on PPIs.
- Subjects who have demonstrated a baseline 24 Hour pH ≥ 4% time with pH ≤ 4.0.
- Subjects with a baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥ 20 off PPI.
- Diagnosis and main criteria for exclusion:
- Extensive Barrett's Esophagus (\> 2 cm).
- Esophagitis (LA Classification Grades C or D).
- Previous history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal or gastric cancer.
- Large hiatal hernia (\> 3 cm).
- Current complaints of clinical dysphagia evidenced by greater than one occurrence per month.
- Esophageal strictures
- Esophageal or gastric varices
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00200044
Start Date
December 1 2002
End Date
June 1 2008
Last Update
July 13 2009
Active Locations (11)
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1
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San Francisco, California, United States, 94115
2
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Atlanta, Georgia, United States, 30322
3
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Chicago, Illinois, United States, 60611
4
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Indianapolis, Indiana, United States, 46202