PillCam® Platform With the PillCam Crohn's Disease Capsule

Inclusion Criteria

• Subject ages 18-75 years, inclusive
• Subject has known CD and signs and symptoms of active disease including one of the following:
• Chronic diarrhea
• Chronic abdominal pain
• Rectal bleeding
• Subject has at least one of the following within three months of 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)
• Weight loss
• Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment.
• Subject agrees to sign consent form

Exclusion Criteria

• Indeterminate Colitis
• Ulcerative Colitis
• Antibiotic Associated Colitis
• Stool positive for Ova &Parasite and for Clostridium difficile toxin within 3 months of enrollment
• Other known infectious cause of increased symptoms
• Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
• Definite long stricture seen on radiological exam.
• Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) 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 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.
• 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 suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
• Subject has Type I or Type II Diabetes.
• Subject has any allergy or other known contraindication to the medications used in the study.
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
• Concurrent participation in another clinical trial using any investigational drug or device.
• 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.