GERDNCT00229086
Gatekeeper European 005
An observational study of GERD, run by MedtronicNeuro at 2 sites in 2 countries.
Trial summary
Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GERD
- What is being tested?
- Gatekeeper Reflux Repari System (Device)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study
- Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent
Who cannot join
- Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)
- Developed other medical illness that may cause the subject to be non-compliant
- Extensive Barrett's Esophagus (>2 cm)
- Unable or unwilling to cooperate with the study procedures
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Contact Medtronic for specific site information
Minneapolis, Minnesota, 44126
About this study
Official title: Long Term Follow-up European Gatekeeper Study 005
Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04
- Conditions
- GERD
- Being tested
- Gatekeeper Reflux Repari System (Device)
- 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 Repari System (Device)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Observational
- Enrolment
- 55 participants
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medtronic GU Investigator, Principal investigator, MedtronicNeuro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229086
- Sponsor's protocol ID
- MGU-004
- Status last verified
- Jul 2008
- First submitted
- 27 Sep 2005
- Last updated
- 28 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up European Gatekeeper Study 005
- ClinicalTrials.gov ID
- NCT00229086
- Acronym / sponsor ID
- MGU-004
- Conditions
- GERD
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 55 participants
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- First posted
- 29 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.
Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study
- Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent
Key exclusion criteria (4 listed)
- Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)
- Developed other medical illness that may cause the subject to be non-compliant
- Extensive Barrett's Esophagus (>2 cm)
- Unable or unwilling to cooperate with the study procedures
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 Repari System (Device) | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2008.
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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.
Medtronic GU Investigator principal investigator
MedtronicNeuro
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by MedtronicNeuro at 2 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?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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 28 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Switzerland. 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. 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. 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.
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 28 Jul 2008.