- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02184754
Magnetic Endoscope Imaging in Single-balloon-enteroscopy (Magenta)
January 28, 2015 updated by: Technical University of Munich
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
München, Bavaria, Germany, 81675
- Klinikum Rechts der Isar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
endoscopy unit
Description
Inclusion Criteria:
- indication for enteroscopy
Exclusion Criteria:
- contraindication for enteroscopy
- patients with cardiac pacemaker or defibrillator
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MEI
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
January 2, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 9, 2014
Study Record Updates
Last Update Posted (Estimate)
January 29, 2015
Last Update Submitted That Met QC Criteria
January 28, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 12-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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