Magnetic Endoscope Imaging in Single-balloon-enteroscopyMagentaNCT02184754
Magnetic Endoscope Imaging in Single-balloon-enteroscopy
An observational study of Magnetic Endoscope Imaging in Single-balloon-enteroscopy, run by Technical University of Munich at 1 site in Germany.
Trial summary
Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in which scope navigation is particularly important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Endoscope Imaging in Single-balloon-enteroscopy
- What is being tested?
- Magnetic endoscope imaging (MEI)
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: endoscopy unit
Who may be able to join
- indication for enteroscopy
Who cannot join
- contraindication for enteroscopy
- patients with cardiac pacemaker or defibrillator
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in which scope navigation is particularly important. The MEI will be compared with x-ray which is still the current gold standard for scope navigation in small bowel enteroscopy.
- Being tested
- Magnetic endoscope imaging (MEI)
- Keywords
- Magnetic endoscope imaging, single-balloon-enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic endoscope imaging (MEI)Procedure or surgery
Also called Olympus MAJ-Y0158
| Study group | Role | What they receive |
|---|---|---|
| MEI | Not described Receives: Procedure: Magnetic endoscope imaging (MEI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of concordance of MEI- and x-ray-images
Immediately after each examination MEI-images and x-ray-images will be analyzed for concordance
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Endoscope Imaging in Single-balloon-enteroscopyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184754
- Sponsor's protocol ID
- 12-2014
- Acronym
- Magenta
- Status last verified
- Jan 2015
- First submitted
- 2 Jan 2014
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Endoscope Imaging in Single-balloon-enteroscopy
- ClinicalTrials.gov ID
- NCT02184754
- Acronym / sponsor ID
- Magenta / 12-2014
- Keywords
- Magnetic endoscope imaging, single-balloon-enteroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jul 2014 (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.
Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in which scope navigation is particularly important. The MEI will be compared with x-ray which is still the current gold standard for scope navigation in small bowel enteroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEI | – | Procedure: Magnetic endoscope imaging (MEI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- endoscopy unit
Key inclusion criteria (1 listed)
- indication for enteroscopy
Key exclusion criteria (3 listed)
- contraindication for enteroscopy
- patients with cardiac pacemaker or defibrillator
- pregnancy
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 |
|---|---|---|
| Magnetic endoscope imaging (MEI)Also: Olympus MAJ-Y0158 | Procedure or surgery | MEI |
Primary outcome
Number of concordance of MEI- and x-ray-images
Time frame: 5 days
Immediately after each examination MEI-images and x-ray-images will be analyzed for concordance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Endoscope Imaging in Single-balloon-enteroscopy, run by Technical University of Munich at 1 site in Germany.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of concordance of MEI- and x-ray-images (time frame: 5 days). 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 29 Jan 2015.