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

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Colon Capsule Endoscopy
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn Disease focused on measuring Crohn Disease, Crohn's Disease Endoscopy Index of Severity, Colon Capsule Endoscopy, Crohn's Disease located in colon and/or ileum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Beaujon
  • Chru Lille
  • Chu Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exam with colon capsule

Arm Description

Colon Capsule Endoscopy

Outcomes

Primary Outcome Measures

Data obtained by the colon capsule endoscopy as a Measure of safety

Secondary Outcome Measures

Reproducibility of the identification of the different anatomic segments on the CCE recordings
Reproducibility of the detection of each lesion

Full Information

First Posted
September 11, 2009
Last Updated
April 26, 2015
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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1. Study Identification

Unique Protocol Identification Number
NCT01183845
Brief Title
Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease
Acronym
CAPSCOL
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn Disease, Crohn's Disease Endoscopy Index of Severity, Colon Capsule Endoscopy, Crohn's Disease located in colon and/or ileum

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exam with colon capsule
Arm Type
Experimental
Arm Description
Colon Capsule Endoscopy
Intervention Type
Procedure
Intervention Name(s)
Colon Capsule Endoscopy
Intervention Description
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
Primary Outcome Measure Information:
Title
Data obtained by the colon capsule endoscopy as a Measure of safety
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Reproducibility of the identification of the different anatomic segments on the CCE recordings
Time Frame
1 month
Title
Reproducibility of the detection of each lesion
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEMANN Marc
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alain ATTAR, MD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Chu Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

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Citation
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Citation
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Links:
URL
http://www.getaid.org
Description
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Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease

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