Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy (CAPSCDEIS)
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First Received Date ICMJE | June 26, 2007 | ||||
Last Updated Date | April 16, 2012 | ||||
Start Date ICMJE | March 2007 | ||||
Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
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Change History | Complete list of historical versions of study NCT00492791 on ClinicalTrials.gov Archive Site | ||||
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Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy | ||||
Official Title ICMJE | Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy | ||||
Brief Summary | The endoscopic capsule is a new tool for exploration of the small intestine. The superiority of this technique on the radiological conventional examinations was shown in Crohn's disease. However no standardization of the lesions exists and no score of severity was proposed. The objective of this exploratory and multicentric study is to develop and validate an endoscopic score of severity especially dedicated to the examination by endoscopic capsule of the small intestine. Hundred twenty patients reached of disease of Crohn corresponding to various groups of severity will be included and will have an examination by video-capsule. The recorded examinations will be the standardized collection of all the lesions observed by independent readers, which will make it possible to evaluate the level of reproducibility of the detection of each lesion. Moreover, each reader will provide his total, qualitative and quantitative evaluations, of the severity of the attack of the small intestine. By using the data of only one reader, a score of severity will be built by simple linear function of the reproducible lesions observed. This score will be validated from the data corresponding to other readers of the same examinations, and those corresponding to another sample. Lastly, the aptitude of this score to detect the changes of the severity of the attack of the small intestine and to define the endoscopic cicatrization will be evaluated from data obtained among patients before and after treatment by infliximab or corticoids |
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Detailed Description | primary objective:Development and validation of an endoscopic score of severity of the small intestine adapted to its exploration by capsule among patients with crohn's disease secondary objectives:
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Probability Sample | ||||
Study Population | Active or quiescent Crohn's Disease |
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Condition ICMJE | Crohn's Disease | ||||
Intervention ICMJE | Device: wireless endoscopy capsule
Firslty patency ingestion then wireless endoscopy capsule exam done |
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Study Group/Cohort (s) | Endoscopic Capsule
Patient enrolled for performing an endoscopic capsule
Intervention: Device: wireless endoscopy capsule |
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Publications * | |||||
* 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 | Completed | ||||
Enrollment ICMJE | 158 | ||||
Completion Date | December 2011 | ||||
Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Belgium, France | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00492791 | ||||
Other Study ID Numbers ICMJE | GETAID 2006-2 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | ||||
Study Sponsor ICMJE | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | ||||
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Information Provided By | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |