Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

Inclusion Criteria:

1. 45-75 years of age

2. Committed to undergo a colonoscopy.

3. Choose to participate and must have signed the IRB-approved informed consentdocument and agreed to release colonoscopy images and results report to Sponsor

Exclusion Criteria:

1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps

2. Has contraindication for capsule endoscopy or colonoscopy

3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditarynon polyposis colon cancer, or any high-risk genetic syndrome

4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerativecolitis or Crohn's disease

5. History of incomplete colonoscopy

6. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within thepast 3 months and/or with history of constipation or gastroparesis).

7. Impaired cardiac function assessed as greater than NYHA Class II

8. History of small- or large-bowel obstructive condition

9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathiesand/or radiation enteritis

10. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on aregular basis that, in the opinion of the Investigator, would put the subject atgreater risk for capsule endoscope retention

11. Known allergy to ingredients used in bowel preparation and boosters

12. Daily and/or regular narcotic use

13. Decompensated cirrhosis

14. Prior abdominal radiation therapy

15. Diagnosis of anorexia or bulimia

16. History of or suspicion of any of the following: strictures, volvulus or intestinalobstruction, or internal hernias or abdominal surgeries that the Investigatorbelieves should exclude the patient from study participation

17. Known or suspected megacolon

18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule

19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis

20. Pregnant or nursing or of child-bearing potential and does not agree to practicemedically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening.

21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures

22. Any documented medical or psychological condition or significant concurrent illnesswhich, in the Investigator's opinion, would make it unsafe for the subject toparticipate in this research study or would affect the validity of the study results

23. Are currently enrolled in an interventional clinical study or currently enrolled inor within the last 30 days, a pharmaceutical clinical study

24. Chronic constipation as defined by <3 bowel movements per week, or the use ofroutine laxatives (other than fiber) to attain regular bowel movements