Lack of efficacy

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.

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

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