Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study
Crohn's Disease
About this trial
This is an interventional diagnostic trial for Crohn's Disease focused on measuring Capsule endoscopy, Crohn's disease, IBD, Activity score, Small bowel, Crohn's disease of the small bowel in any stage, Recruiting
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older and not greater than 80 years suffer from Crohn's Disease of the small bowel, documented by clinical, endoscopical, histopathological and radiological parameters, in any activity stage iof the disease and any treatment
- Documented written Informed Consent
Exclusion Criteria:
- Subject suffers from swallowing difficulties
- Female subject is pregnant or nursing (in case of necessary small bowel series a pregnancy test has to be performed prior to the test)
- Subject is known to suffer from intestinal obstruction
- Subject has a cardiac pacemakers or other implanted electro medical devices
- Patients with more than 40% small bowel resect
- 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 with colonic involvement of Crohn's disease
Sites / Locations
- Triniti College
- Hillel Jafa Medical Center
- Rabin Medical Center, Beilinson Hospital, Tel Aviv University
- Asaf Harofe Medical Center
Arms of the Study
Arm 1
Experimental
Device
Patient preparation procedure will be done according to chapter 4 in the Given Diagnostic System user manual. In brief: to drink only clear liquids beginning 12:00 noon the day before.at least 8 hours (since 12:00 PM) fast prior to the procedure. Patient will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion. Eight hours post ingestion, data recorder will be removed and the patient will be dismissed. A local experienced reader will review the RAPID video to determine the diagnosis blinded to the results of the standard workup procedures, and to each other results. Results will be recorded in the case report forms. A decoded video will be transferred to the principal investigator for reevaluation