When you arrive, the nurse will explain what will be done before, during and after the Pillcam® Endoscopy. Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease. history, physical exams, labs) and a recent history of mucosal disease (within the last 2 years and diagnosis based on radiologic, endoscopic, or histologic findings) OR subjects with known CD and active disease based on clinical judgment based on symptoms, laboratory data or other clinical information will undergo Magnetic Resonance Enterography (MRE), Capsule Endoscopy (CE) and Ileocolonoscopy (IC), to assess presence or absence of CD across the small and large bowel. 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. The expected duration of each subject's participation is approximately 1 month. Subject has any condition, which precludes compliance with study and/or device instructions. Please remove one or more studies before adding more. Why Should I Register and Submit Results? COVID-19 is an emerging, rapidly evolving situation. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Subjects with known or suspected delayed gastric emptying, Subjects with known or suspected delayed Small bowel motility. Patient satisfaction questionnaire will be completed at baseline. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. There will be assessment of mucosal disease activity at baseline. Please remove one or more studies before adding more. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score. Shanghai Jiao Tong University School of Medicine. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Choosing to participate in a study is an important personal decision. Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times per week, during the 4 weeks preceding enrollment. ", Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin), Anemia (hemoglobin level below normal reference range), Hypoalbuminemia (albumin below normal reference range). Other: Pillcam colon capsule and PillCam™ Prep Procedure. Why Should I Register and Submit Results? COVID-19 is an emerging, rapidly evolving situation. The system features advanced optics and imaging designed to deliver exceptional images of the mucosa. A consensus panel will be used if there are discrepancies in results between modalities at baseline. regular biopsy was taken during conventional colonoscopy according to the activity and position of ulcerative colitis involved. academic hospital endoscopist of digestive department. Subject has known CD and a recent history (within last 2 years) of mucosal disease (based on radiologic, endoscopic, or histologic evidence) OR known CD and active disease, based on clinical judgment based on symptoms, laboratory data or other clinical information. Subjects will be enrolled at up to 40 sites in the United States, Israel, and Austria. Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa.

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