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

Sponsor
MedtronicNeuro (Industry)
Overall Status
Terminated
CT.gov ID
NCT00200044
Collaborator
(none)
143
Enrollment
11
Locations
2
Arms
66
Duration (Months)
13
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Gatekeeper Reflux Repair System
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Gatekeeper® System Sham-Controlled Study for the Treatment of GERD
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • Gatekeeper

    		•
    Active Comparator: Treatment

    The treatment arm has the Gatekeeper devices implanted.

    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 Names:
  • Gatekeeper

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in serious device and procedure related adverse device effects. [6 months]

    Secondary Outcome Measures

    1. Improvement in espophageal pH [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Contact Medtronic for specific site information San Francisco California United States 94115
    2 Contact Medtronic for specific site information Atlanta Georgia United States 30322
    3 Contact Medtronic for specific site information Chicago Illinois United States 60611
    4 Contact Medtronic for specific site information Indianapolis Indiana United States 46202
    5 Contact Medtronic for specific site information Lexington Kentucky United States 40536
    6 Contact Medtronic for specific site information St. Louis Missouri United States 63110
    7 Contact Medtronic for specific site information Lebanon New Hampshire United States 03756
    8 Contact Medtronic for specific site information New York New York United States 10021
    9 Contact Medtronic for specific site information Knoxville Tennessee United States 37909
    10 Contact Medtronic for specific site information Milwaukee Wisconsin United States 53233
    11 Contact Medtronic for specific site information Amsterdam Netherlands

    Sponsors and Collaborators

    • MedtronicNeuro

    Investigators

    • Principal Investigator: Glen Lehman, Indiana University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00200044
    Other Study ID Numbers:
    • MGU - 002
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Jul 13, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    GERD
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophagitis, Peptic

    Study Results

    No Results Posted as of Jul 13, 2009