NCT00200044 - An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD) | Biotech Hunter

Enrollment

143

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

June 30, 2006

Study Completion Date

June 30, 2008

Conditions

Gastroesophageal Reflux Disease

Interventions

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.

Trial Locations (11)

10021

Contact Medtronic for specific site information, New York

30322

Contact Medtronic for specific site information, Atlanta

37909

Contact Medtronic for specific site information, Knoxville

40536

Contact Medtronic for specific site information, Lexington

46202

Contact Medtronic for specific site information, Indianapolis

53233

Contact Medtronic for specific site information, Milwaukee

60611

Contact Medtronic for specific site information, Chicago

63110

Contact Medtronic for specific site information, St Louis

94115

Contact Medtronic for specific site information, San Francisco

03756

Contact Medtronic for specific site information, Lebanon

Unknown

Contact Medtronic for specific site information, Amsterdam