Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2021
• Main ID: NCT02193802
• Date of registration: 16/07/2014
• Prospective Registration: No
• Primary sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Public title: Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease CHANCE
• Scientific title: Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease
• Date of first enrolment: May 2014
• Target sample size: 42
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02193802
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France, Spain

Contacts

• Name: Dr Arnaud Bourreille, MD
• Affiliation: CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject aged more than 18 years

- Subject with at least ileal lesions of Crohn's disease

- Subject with moderate to severe Crohn's disease at baseline, as defined by CDAI > 150,

- Subject accepting to undergo two capsules endoscopy and Ileocolonoscopy procedures

- Proven patency by Agile capsule or another approach deemed clinically acceptable by
the investigator, e.g. CT enterography or MRI enterography, performed within the 6
months prior to enrollment

Exclusion Criteria:

- Known gastrointestinal obstruction or strictures based on the clinical picture or pre
procedure testing and profile

- Cardiac pacemakers or other implanted electromedical devices

- Swallowing disorders.

- Subject with known slow gastric emptying

- Contraindications to ileocolonoscopy or general anasthesia

- Subject with any condition, which precludes compliance with study and/or device
instructions

- Women who are either pregnant or nursing at the time of screening, who intend to be
during the study period, or are of child-bearing potential and do not practice
medically acceptable methods of contraception.

- Subject suffers from life threatening conditions

- Subject currently participating in another clinical study

- Subject has taken NSAID medications less than one month before enrollment



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Device: PillCam® COLON 2 and PillCam Crohn's capsules

Primary Outcome(s)

Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment. [Time Frame: week 0 and after 6 at 12 months]

Secondary Outcome(s)

Segmental ileal and global CDEIS score [Time Frame: week 0 and after 6 at 12 months]

Lewis score [Time Frame: week 0 and after 6 at 12 months]

Secondary ID(s)

2013-A00034-41

GETAID 2012-3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors