Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease (CAPSCOL)
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|ClinicalTrials.gov Identifier: NCT01183845|
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : April 28, 2015
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 lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's Disease Endoscopic Index of Severity is the main score used in controlled trials to assess the endoscopic severity of lesions in Crohn's Disease.
The investigators aim to conduct a prospective pilot study primarily to evaluate the applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule endoscopy lead to comparable overall severity evaluations.
Secondary objectives are to assess reproducibility of the reading of data obtained by CCE and to compare these data with those obtained by conventional ileocolonoscopy. If overall severity evaluations derived from the two examinations are not comparable, the secondary objectives will be used in an attempt to understand the reasons of this discrepancy.
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Procedure: Colon Capsule Endoscopy||Phase 4|
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 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.
- Previous imaging of small bowel (one or more) by Small Bowel Follow Through (SBFT), Magnetic Resonance Enteroclysis (MRE) or Computed Tomography Enterography (CTE) performed in the last 12 months
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate the Applicability of the Crohn's Disease Endoscopy Index of Severity to Data Obtained by the Colonic Capsule Endoscopy in Ileocolonic Crohn's Disease|
|Study Start Date :||April 2009|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Experimental: Exam with colon capsule
Colon Capsule Endoscopy
Procedure: Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
- Data obtained by the colon capsule endoscopy as a Measure of safety [ Time Frame: 1 month ]
- Reproducibility of the identification of the different anatomic segments on the CCE recordings [ Time Frame: 1 month ]
- Reproducibility of the detection of each lesion [ Time Frame: At inclusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183845
|Clichy, France, 92110|
|Lille, France, 59037|
|Nantes, France, 44093|
|Study Director:||LEMANN Marc||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|
|Principal Investigator:||Alain ATTAR, MD||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|