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

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:
  • Olympus MAJ-Y0158

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.

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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