Back to resultsAn Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Gastroesophageal Reflux Disease
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Gatekeeper Reflux Repair System
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD
Eligibility Criteria
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
Sites / Locations
- Contact Medtronic for specific site information
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Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham
Treatment
Arm Description
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.
The treatment arm has the Gatekeeper devices implanted.
Outcomes
Primary Outcome Measures
Reduction in serious device and procedure related adverse device effects.
Secondary Outcome Measures
Improvement in espophageal pH
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00200044
Brief Title
An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
Official Title
Gatekeeper® System Sham-Controlled Study for the Treatment of GERD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
December 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MedtronicNeuro
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
The treatment arm has the Gatekeeper devices implanted.
Intervention Type
Device
Intervention Name(s)
Gatekeeper Reflux Repair System
Other Intervention Name(s)
Gatekeeper
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in serious device and procedure related adverse device effects.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in espophageal pH
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen Lehman
Organizational Affiliation
Indiana University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
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City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
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City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
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City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
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City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
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City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
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City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
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City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
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City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
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City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
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City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
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City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
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