An evaluation of the Medtronic Gatekeeper system in the treatment of subjects with Gastroesophageal reflux disease (GERD).

The Gatekeeper procedure involves the placement of polyacrylonitrile-based hydrogel prostheses into the esophageal submucosal space of the lower esophageal sphincter to prevent reflux.

The Gatekeeper Reflux Repair System offers several advantages to using standard surgical repair or other current endoscopic procedures. These advantages include the ability of the clinician to easily place the prostheses, and placement of the prostheses is reversible.




The purpose of this investigation is to demonstrate the intended use of the Medtronic Gatekeeper Reflux Repair System to provide symptomatic relief in subjects diagnosed with GERD.




It is a prospective, randomized, sham-controlled, single-blinded, multicenter study with an approximate total of 144 implanted male and female subjects with gastroesophageal reflux disease showing symptomatic improvement on proton pump inhibitors who satisfy all entry criteria.
These subjects will be randomized to receive the Gatekeeper prostheses or to the sham control group with 96 subjects in the treatment arm and 48 subjects in the sham control arm.

All subjects in the sham control group will be given the option of crossing over to the active treatment group after a minimum period of 6 months has transpired following the initial sham procedure.

All subjects will be followed closely for up to 18 months ( depending on their randomization group), and then once a year after that until the study closes.




Primary endpoints:

Serious device- and procedure-related adverse device effects (whether anticipated or unanticipated), at 6 months post-procedure and the subjects’ associated symptoms of heartburn at 6-months post-Gatekeeper procedure.




Secondary endpoints:

Improved esophageal pH defined as the total percent of time that pH is less than 4 at 6 months post-Gatekeeper procedure as compared to baseline.

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The subjects will be randomized to receive the Endoscopy Gatekeeper prostheses or to the endoscopy sham control group with 96 subjects in the treatment arm and 48 subjects in the sham control arm. At 6 months following the initial implant'sham procedure, the blind will be broken for all subjects and those randomized to receive the sham procedure will have the opportunity to receive the Gatekeeperprocdure. All subjects will complete Symptom Assesment and Quality of Life questionnaires in the screening procedure and at 6 weeks, 3, 6 12 months and annualy until study closure. Upper endoscopy will be performed in the screening procedure and at 3, 6 and 12 months. Esophageal manometry and 48 hours Bravo pH studies will be performed in the screening procedure and at 6 and 12 months. All subjects must discontinue any PPI therapy at least 7 days prior to study visits. 2 weeks after the procedure all subjects will be directed to discontinue their PPI therapy. After discontinuation of PPi's subjects who have persistent symptoms of heartburn or regurgitation may be given anti-reflux medication using the treatment regimen as described in the protocol.