Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492791
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2007-06-26
Brief Title:
Endoscopic Severity Score of Small Bowel Crohns Disease With Wireless Capsule Endoscopy
Sponsor:
Groupe dEtude Therapeutique des Affections Inflammatoires Digestives
Organization:
Groupe dEtude Therapeutique des Affections Inflammatoires Digestives
Study Overview
Official Title:
Development and Validation of an Endoscopic Severity Score of Small Bowel Crohns Disease With Wireless Capsule Endoscopy
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPSCDEIS
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 Crohns 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
Detailed Description:
primary objectiveDevelopment and validation of an endoscopic score of severity of the small intestine adapted to its exploration by capsule among patients with crohns disease secondary objectives
Study of the reproducibility of the detection of the lesions
total evaluation of the severity of the small intestine on an ordinal scale with 5 classes and on a continuous analogical scale
Study and validation of the sensitivity to the change of the score of severity variation among patients after treatment by Infliximab or corticoids
Evaluation of the aptitude of the endoscopic score of severity to define the endoscopic cicatrization
Study of the correlation between the endoscopic score of severity and a clinical marker of activity Crohn S Disease Activity Index CDAI and a marker of inflammation serum level of C-Reactive protein CRP
Validation of the utility of Patency Agile used before the capsule All the patients included will have before their endoscopic capsule an examination by patency After validation the patients will have an exploration by the video capsule The readers will fill a grid with standardized lesions The films will be read by two other independent readers The patients treated by infliximab or prednisone will have one second capsule afterwards 10 weeks
Study of the reproducibility of the detection of the lesions
total evaluation of the severity of the small intestine on an ordinal scale with 5 classes and on a continuous analogical scale
Study and validation of the sensitivity to the change of the score of severity variation among patients after treatment by Infliximab or corticoids
Evaluation of the aptitude of the endoscopic score of severity to define the endoscopic cicatrization
Study of the correlation between the endoscopic score of severity and a clinical marker of activity Crohn S Disease Activity Index CDAI and a marker of inflammation serum level of C-Reactive protein CRP
Validation of the utility of Patency Agile used before the capsule All the patients included will have before their endoscopic capsule an examination by patency After validation the patients will have an exploration by the video capsule The readers will fill a grid with standardized lesions The films will be read by two other independent readers The patients treated by infliximab or prednisone will have one second capsule afterwards 10 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None