Clinical trial NCT00200044: An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
Official title: Gatekeeper® System Sham-Controlled Study for the Treatment of GERD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Reduction in serious device and procedure related adverse device effects.
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in espophageal pH
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Contact Medtronic for specific site information
state: California
city: Atlanta
country: United States
facility: Contact Medtronic for specific site information
state: Georgia
city: Chicago
country: United States
facility: Contact Medtronic for specific site information
state: Illinois
city: Indianapolis
country: United States
facility: Contact Medtronic for specific site information
state: Indiana
city: Lexington
country: United States
facility: Contact Medtronic for specific site information
state: Kentucky
city: St. Louis
country: United States
facility: Contact Medtronic for specific site information
state: Missouri
city: Lebanon
country: United States
facility: Contact Medtronic for specific site information
state: New Hampshire
city: New York
country: United States
facility: Contact Medtronic for specific site information
state: New York
city: Knoxville
country: United States
facility: Contact Medtronic for specific site information
state: Tennessee
city: Milwaukee
country: United States
facility: Contact Medtronic for specific site information
state: Wisconsin
city: Amsterdam
country: Netherlands
facility: Contact Medtronic for specific site information
Study officials:
affiliation: Indiana University Hospital
name: Glen Lehman
role: PRINCIPAL_INVESTIGATOR
References: