Last updated on March 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Inflammatory bowel disease | Crohn's Disease | Crohn's Disease (Pediatric)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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