Status:
COMPLETED
Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and the surface of ...
Detailed Description
Twenty-four patients with CD will be included in the study on the basis of the need for an ileo-colonoscopy whatever the indication. * Males and females patients more than 18-years-old * Known coloni...
Eligibility Criteria
Inclusion
- Males and females patients more than 18-years-old
- Known colonic CD patients with a diagnosis based on established clinical, endoscopic, ra-diologic, and histologic criteria
- Ileocolonoscopy scheduled
- Patients' agreement for the CCE procedure to be performed within the week following the ileocolonoscopy
Exclusion
- Surgery of one or more segment of the colon or terminal ileum
- Non colonic CD
- High risk for capsule retention defined by the presence of clinically significant obstructive symptom related to intestinal or colonic stricture detected by small bowel imaging
- Stenosis of the colon or ileum not passed by the colonoscope
- Treatment with antiTNF or biotherapy after the ileocolonoscopy and before the CCE procedure
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01183845
Start Date
April 1 2009
End Date
June 1 2012
Last Update
April 28 2015
Active Locations (3)
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1
Hopital Beaujon
Clichy, France, 92110
2
Chru Lille
Lille, France, 59037
3
Chu Nantes
Nantes, France, 44093