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

Inclusion Criteria

• Subject ages 2-75 years, inclusive
• Subjects with a diagnosis of known Crohn disease
• Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)
• Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.
• Subject or parent agrees to sign consent form

Exclusion Criteria

The presence of any of the following will exclude a subject from study enrollment:

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