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

Exclusion Criteria

• •1. Subject has a history of colorectal cancer
• •2. Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.)
• •3. 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
• •4. 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.
• •5. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome.
• •6. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
• •7. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding, including positive FOBT test of any variety.
• •8. Subject is suspected or diagnosed with bowel obstruction.
• •9. Subject has dysphagia or any swallowing disorder.
• •10. Subject has congestive heart failure.
• •11. Subject has Type 1 or Type II Diabetes.
• •12. 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.
• •13. Subject has a cardiac pacemaker or other implanted electro medical device.
• •14. Subject has any allergy or other known contraindication to the medications used in the study.
• •15. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• •16. 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.
• •17. Subject with strictures, fistulas and/or chronic constipation.
• •18. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
• •19. Subject with known gastrointestinal motility disorders.
• •20. Subject has known delayed gastric emptying.
• •21. Subject has any condition, which precludes compliance with study and/or device instructions.
• •22. 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.
• •23. Subject suffers from life threatening conditions.
• •24. Concurrent participation in another clinical trial using any investigational drug or device.