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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00200044
• Other study ID #: MGU - 002
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: July 10, 2009
• Start date: December 2002
• Est. completion date: June 2008

Study information

• Verified date: July 2009
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: June 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• Gatekeeper 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.

Locations

Country	Name	City	State
Netherlands	Contact Medtronic for specific site information	Amsterdam
United States	Contact Medtronic for specific site information	Atlanta	Georgia
United States	Contact Medtronic for specific site information	Chicago	Illinois
United States	Contact Medtronic for specific site information	Indianapolis	Indiana
United States	Contact Medtronic for specific site information	Knoxville	Tennessee
United States	Contact Medtronic for specific site information	Lebanon	New Hampshire
United States	Contact Medtronic for specific site information	Lexington	Kentucky
United States	Contact Medtronic for specific site information	Milwaukee	Wisconsin
United States	Contact Medtronic for specific site information	New York	New York
United States	Contact Medtronic for specific site information	San Francisco	California
United States	Contact Medtronic for specific site information	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in serious device and procedure related adverse device effects.		6 months
Secondary	Improvement in espophageal pH		6 months