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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT01576120
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 years of age and above
* Subjects who are determined by their physician to have active Crohn's disease based on at least one of the following tests which were performed in the past 3 months :
* Colonoscopy
* Capsule endoscopy of the small bowel or colon
* Other radiology tests
* Clinical symptoms with elevated positive inflammatory markers ;ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, or fecal alpha-1 antitrypsin
* Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
* Subject is able and agrees to sign the Informed Consent Form
Exclusion Criteria:
* • Subject has dysphagia
* Subject has congestive heart failure
* Subject has renal insufficiency
* Subject has cirrhosis
* Subject is known or is suspected to suffer from intestinal obstruction
* Subject has known previous stricture/obstruction of the SB or colon
* Chronic use of laxatives
* Subject has a cardiac pacemaker or other implanted electro medical device.
* 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 is expected to undergo MRI examination within 7 days after ingestion of the capsule.
* Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
* Subject has any condition, which precludes compliance with study and/or device instructions.
* Subject suffers from life threatening conditions
* Subject is currently participating in another clinical study
* Subject has known slow gastric emptying time or GI transit time.
* Subject is allergic or contraindicated to any of the study medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01576120
Study Brief:
Protocol Section:
NCT01576120