NCT00200044

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-12-01
• Primary completion: 2006-06-01
• Completion: 2008-06-01
• First posted: 2005-09-20
• Last updated: 2009-07-13

Locations

11 sites across 2 countries: United States, Netherlands