Back to resultsComparison of MR Enteroclysis and MRI With Per Oral Contrast Using a 6 % Mannitol Solution.
Primary Purpose
Magnetic Resonance Imaging, Intestine Small, Crohn Disease.
Status
Unknown status
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
MRI of the small bowel
Sponsored by
About this trial
This is an interventional diagnostic trial for Magnetic Resonance Imaging, Intestine Small, Crohn Disease.
Eligibility Criteria
Inclusion Criteria: above 18 years known Crohns disease or strong suspicion. need of a small bowel examination Exclusion Criteria: pregnant electrolyte disturbances. Any MRI contraindications.
Sites / Locations
- Ulleval Universitets sykehus
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00204165
First Posted
September 13, 2005
Last Updated
September 7, 2006
Sponsor
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT00204165
Brief Title
Comparison of MR Enteroclysis and MRI With Per Oral Contrast Using a 6 % Mannitol Solution.
Official Title
MRI of the Small Bowel. Comparison of Different Techniques and Contrast.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oslo
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare MRI enteroclysis with MRI of the small bowel with a per oral 6%mannitol solution.Our hypothesis is that the peroral technique preform the same way as MRI Enteroclysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Resonance Imaging, Intestine Small, Crohn Disease.
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
MRI of the small bowel
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
above 18 years
known Crohns disease or strong suspicion.
need of a small bowel examination
Exclusion Criteria:
pregnant
electrolyte disturbances.
Any MRI contraindications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils-Einar Kløw, Prof. MD
Organizational Affiliation
Ulleval Universitetssykehus
Official's Role
Study Director
Facility Information:
Facility Name
Ulleval Universitets sykehus
City
Kirkeveien 166
State/Province
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
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Comparison of MR Enteroclysis and MRI With Per Oral Contrast Using a 6 % Mannitol Solution.
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