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

Study Overview
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Brief Summary
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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
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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

Official Title
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Gatekeeper® System Sham-Controlled Study for the Treatment of GERD

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Device: Gatekeeper Reflux Repair System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>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. | Device: Gatekeeper Reflux Repair System<br>* The Gatekeeper System™ consists of a specialized 16-mm overtube assembly, a 2.4-mm diameter prosthesis delivery system (1-mm diameter needle, dilator, and 2.4-mm diameter sheath), a pushrod assembly and Gatekeeper Prosthesis. Up to 4 prostheses will be implanted at the initial procedure and retreatment with up to four more prostheses will be allowed at 3-months if the subject has a GERD HRQL score >15.<br>* Other names: Gatekeeper;|
| Active Comparator: Treatment<br>The treatment arm has the Gatekeeper devices implanted. | Device: Gatekeeper Reflux Repair System<br>* The Gatekeeper System™ consists of a specialized 16-mm overtube assembly, a 2.4-mm diameter prosthesis delivery system (1-mm diameter needle, dilator, and 2.4-mm diameter sheath), a pushrod assembly and Gatekeeper Prosthesis. Up to 4 prostheses will be implanted at the initial procedure and retreatment with up to four more prostheses will be allowed at 3-months if the subject has a GERD HRQL score >15.<br>* Other names: Gatekeeper;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in serious device and procedure related adverse device effects. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in espophageal pH |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD