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

NCT01183845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-04-28

No results posted yet for this study

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 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.

Conditions

  • Crohn Disease

Interventions

PROCEDURE

Colon Capsule Endoscopy

Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • LEMANN Marc · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • Alain ATTAR, MD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183845 on ClinicalTrials.gov