Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon

Inclusion Criteria

• Subject is between 50 - 75 years of age, and is classified as average risk per the AGA Guidelines on CRC Screening.
• Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion Criteria

• Subject has a history of colorectal cancer
• Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.)
• Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) < 5 years as these subjects would be defined not requiring screening in this time frame
• Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
• Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome.
• Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
• Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding, including positive FOBT test of any variety.
• Subject is suspected or diagnosed with bowel obstruction.
• Subject has dysphagia or any swallowing disorder.
• Subject has congestive heart failure.
• Subject has Type 1 or Type II Diabetes.
• 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 has a cardiac pacemaker or other implanted electro medical device.
• Subject has any allergy or other known contraindication to the medications used in the study.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
• Subject with strictures, fistulas and/or chronic constipation.
• Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
• Subject with known gastrointestinal motility disorders.
• Subject has known delayed gastric emptying.
• 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.
• Subject suffers from life threatening conditions.
• Concurrent participation in another clinical trial using any investigational drug or device.