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Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease (CAPSCOL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT01183845
First received: September 11, 2009
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Crohn Disease
Procedure: Colon Capsule Endoscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:
  • Data obtained by the colon capsule endoscopy as a Measure of safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reproducibility of the identification of the different anatomic segments on the CCE recordings [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Reproducibility of the detection of each lesion [ Time Frame: At inclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: April 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exam with colon capsule
Colon Capsule Endoscopy
Procedure: Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.

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 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183845

Locations
France
Hopital Beaujon Recruiting
Clichy, France, 92110
Contact: Yoram BOUHNIK, MD,PhD    +33 1 40 87 56 00    yoram.bouhnik@bjn.aphp.fr   
Principal Investigator: YORAM BOUHNIK, MD,PhD         
Sub-Investigator: Alain ATTAR, MD         
Sub-Investigator: Carmen STEFANESCU, MD         
Sub-Investigator: Xavier TRETON, MD         
Chru Lille Recruiting
Lille, France, 59037
Contact: Jean-Frédéric COLOMBEL, MD,PhD    +33 3 20 44 47 14    jean-frederic-colombel@chru-lille.fr   
Contact: Géraldine MEULIN    +33 3 20 44 56 20    g-meulin@chru-lille.fr   
Principal Investigator: Jean-Frédéric COLOMBEL, MD,PhD         
Sub-Investigator: Gwenola VERNIER-MASSOUILLE, MD         
Chu Nantes Recruiting
Nantes, France, 44093
Contact: Arnaud BOURREILLE, MD    +33202400830    arnaud.boureille@chu-nantes.fr   
Principal Investigator: Arnaud BOURREILLE, MD         
Sub-Investigator: Mathurin FLAMANT, MD         
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT01183845     History of Changes
Other Study ID Numbers: GETAID 2008-2
Study First Received: September 11, 2009
Last Updated: August 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Crohn Disease
Crohn's Disease Endoscopy Index of Severity
Colon Capsule Endoscopy
Crohn's Disease located in colon and/or ileum

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014