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

April 26, 2015 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Lille, France, 59037
        • CHRU Lille
      • Nantes, France, 44093
        • Chu Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exam with colon capsule
Colon Capsule Endoscopy
Procedure: Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Data obtained by the colon capsule endoscopy as a Measure of safety
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Reproducibility of the identification of the different anatomic segments on the CCE recordings
Time Frame: 1 month
1 month
Reproducibility of the detection of each lesion
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

August 16, 2010

First Posted (ESTIMATE)

August 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 26, 2015

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2008-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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