An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux Disease
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD
Eligibility Criteria
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
Sites / Locations
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
- Contact Medtronic for specific site information
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Active Comparator
Sham
Treatment
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.
The treatment arm has the Gatekeeper devices implanted.