Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease
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| First Received Date ICMJE | August 20, 2012 | ||||||||
| Last Updated Date | March 5, 2013 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Follow-up of known small bowel Crohn disease [ Time Frame: 1 year ] [ Designated as safety issue: No ] A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01671579 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease | ||||||||
| Official Title ICMJE | Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease. | ||||||||
| Brief Summary | To establish the accuracy of bowel ultrasound in the follow-up of known (previously diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance imaging technology used to obtain detailed images of the small bowel) as the reference standard. |
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| Detailed Description | 25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Crohn Disease | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Pediatric small bowel Crohn disease
Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | August 2016 | ||||||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 10 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01671579 | ||||||||
| Other Study ID Numbers ICMJE | HUM00061688 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jonathan R. Dillman M.D., University of Michigan | ||||||||
| Study Sponsor ICMJE | University of Michigan | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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