Gastroesophageal Reflux Disease
Conditions
Keywords
GERD
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
Interventions
DEVICEGatekeeper Reflux Repair System
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.
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in serious device and procedure related adverse device effects. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in espophageal pH | 6 months |
Countries
Netherlands, United States
Outcome results
None listed