This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below: Visit 1; Screening visit * Informed consent process * screening for eligibility to participate in the study * Inclusion/exclusion criteria * Small bowel patency test * Demographic data * Pregnancy test * General medical history Visit 2; PillCam® Crohn's capsule ingestion * PillCam® CD bowel preparation * Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours) * Ileocolonoscopy with intubation of terminal ileum Follow up period (5-9 days following visit 2) • CE Follow up telephone contac
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
75
PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure • Ileocolonoscopy with intubation of terminal ileum
IU School of Medicine - Gastroenterology
Indianapolis, Indiana, United States
Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon
the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy. The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy. Each patient was classified as follows: * Active Crohn's disease is likely * Active Crohn's disease is NOT likely "Active Crohn's disease" included the followings lesions: * Aphthous ulceration * Ulcers (other than Aphthous) * Bleeding * Inflammatory stricture Lesions other than the above list were classified as "Non active Crohn's disease."
Time frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment
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