CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)

Exclusion Criteria

• •1. History of negative colonoscopy within the last 10 years
• •2. History of incomplete colonoscopy
• •3. Impaired cardiac function assessed as greater than NYHA Class II
• •4. History of small- or large-bowel obstructive condition
• •5. Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis
• •6. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the patient at greater risk for capsule endoscope retention
• •7. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
• •8. Known allergy to ingredients used in bowel preparation and boosters
• •9. Daily and/or regular use of narcotics
• •10. Known or suspected AIDS
• •11. Uncompensated cirrhosis
• •12. Prior abdominal radiation therapy
• •13. Diagnosis of anorexia or bulimia
• •14. History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion
• •15. Known or suspected megacolon
• •16. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
• •17. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
• •18. Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening.
• •19. Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study
• •20. Are currently enrolled in, or participated in within the last 30 days, another clinical study
• •21. Chronic constipation as defined by \<3 bowel movements per week for at least 3 months prior to Screening, or the use of routine laxatives (other than fiber) to attain r regular bowel movements for at least 3 months prior to Screening
• •22. History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator