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

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200044
First received: September 12, 2005
Last updated: July 10, 2009
Last verified: July 2009

September 12, 2005
July 10, 2009
December 2002
June 2006   (final data collection date for primary outcome measure)
Reduction in serious device and procedure related adverse device effects. [ Time Frame: 6 months ]
- Reducion in serious device and procedure related adverse device effects.
Complete list of historical versions of study NCT00200044 on ClinicalTrials.gov Archive Site
Improvement in espophageal pH [ Time Frame: 6 months ]
- Improvement in espophageal pH
Not Provided
Not Provided
 
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

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
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.
Other Name: Gatekeeper
  • Sham Comparator: Sham
    This arm of the study has the procedure but does not get the Gatekeeper prostheses. The Sham arm has the option to cross-over to the Treatment arm at the 6-month visit.
    Intervention: Device: Gatekeeper Reflux Repair System
  • Active Comparator: Treatment
    The treatment arm has the Gatekeeper devices implanted.
    Intervention: Device: Gatekeeper Reflux Repair System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
143
June 2008
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT00200044
MGU - 002
Yes
Chad Giese / Clinical Research Specialist, Medtronic Neuromodulation - Gastroenterology and Urology
MedtronicNeuro
Not Provided
Principal Investigator: Glen Lehman Indiana University Hospital
MedtronicNeuro
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP