Status:
UNKNOWN
Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies. Mucosal healing is a good predictor of long term remission. Unfortunately...
Detailed Description
Crohn's disease is a chronic, inflammatory disorder affecting any part of the gastrointestinal tract but the terminal ileum is the most frequent location involved alone or in combination with other lo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02193802
Start Date
May 1 2014
End Date
March 1 2022
Last Update
July 9 2021
Active Locations (11)
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1
CHU Amiens
Amiens, France, 80054
2
CHU CAEN
Caen, France, 14033
3
CHU Clermont Ferrand
Clermont-Ferrand, France, 63003
4
Hôpital Beaujon
Clichy, France, 92 110