Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02193802
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02193802
Study Brief:
Protocol Section:
NCT02193802