Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

Exclusion Criteria

• •The presence of any of the following will exclude a subject from study enrollment:
• •1. Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE
• •2. Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
• •3. Stricture seen on radiological exam.
• •4. Indeterminate Colitis
• •5. Ulcerative Colitis
• •6. Antibiotic Associated Colitis
• •7. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
• •8. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment
• •9. Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.
• •10. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• •11. Subjects with known or suspected delayed gastric emptying
• •12. Subjects with known or suspected delayed Small bowel motility
• •13. Subject has any allergy or other known contraindication to the medications used in the study.
• •14. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.
• •15. Unwillingness to use a medically accepted method of contraception throughout duration of study
• •16. Concurrent participation in another clinical trial using any investigational drug or device.
• •17. Subject has cardiac pacemaker or other implanted electromedical devices
• •18. Subject suffers from a life threatening condition.
• •19. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
• •20. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.