Gastroesophageal Reflux DiseaseNCT00200044
An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)
A study testing Gatekeeper Reflux Repair System in people with Gastroesophageal Reflux Disease, run by MedtronicNeuro at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Gatekeeper Reflux Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Dec 2002to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Contact Medtronic for specific site information
Atlanta, Georgia, 30322
Contact Medtronic for specific site information
Chicago, Illinois, 60611
Contact Medtronic for specific site information
Indianapolis, Indiana, 46202
Contact Medtronic for specific site information
Knoxville, Tennessee, 37909
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Lebanon, New Hampshire, 03756
Contact Medtronic for specific site information
Lexington, Kentucky, 40536
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Milwaukee, Wisconsin, 53233
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New York, New York, 10021
Contact Medtronic for specific site information
San Francisco, California, 94115
Contact Medtronic for specific site information
St Louis, Missouri, 63110
Netherlands1 site
Contact Medtronic for specific site information
Amsterdam
About this study
Official title: 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.
Read the 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
- Being tested
- Gatekeeper Reflux Repair System
- Keywords
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gatekeeper Reflux Repair SystemDevice
Also called Gatekeeper
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | 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. Receives: Device: Gatekeeper Reflux Repair System |
| Treatment | Active comparator | The treatment arm has the Gatekeeper devices implanted. Receives: Device: Gatekeeper Reflux Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in serious device and procedure related adverse device effects.
Measured: 6 months
Secondary outcomes (1)
Improvement in espophageal pH
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionJun 2006
- Study completionJun 2008
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Glen Lehman, Principal investigator, Indiana University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200044
- Sponsor's protocol ID
- MGU - 002
- Status last verified
- Jul 2009
- First submitted
- 12 Sep 2005
- Last updated
- 13 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gatekeeper® System Sham-Controlled Study for the Treatment of GERD
- ClinicalTrials.gov ID
- NCT00200044
- Acronym / sponsor ID
- MGU - 002
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 143 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Gatekeeper Reflux Repair SystemThis 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. |
| Treatment | Active comparator | Device: Gatekeeper Reflux Repair SystemThe treatment arm has the Gatekeeper devices implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gatekeeper Reflux Repair SystemAlso: GatekeeperThe 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. | Device | Sham, Treatment |
Primary outcome
Reduction in serious device and procedure related adverse device effects.
Time frame: 6 months
1 secondary outcome
Improvement in espophageal pH
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Lehman principal investigator
Indiana University Hospital
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gatekeeper Reflux Repair System in people with Gastroesophageal Reflux Disease, run by MedtronicNeuro at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in serious device and procedure related adverse device effects. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2009.