Clinical Trials

Inclusion Criteria:

1. At least 45-75 years of age

2. Committed to undergo a colonoscopy, independent of this study

3. Choose to participate and must have signed the IRB-approved informed consent document
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, hereditary non
polyposis colon cancer, or any high-risk genetic syndrome

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

5. History of incomplete colonoscopy

6. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within the past
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 neuropathies
and/or radiation enteritis

10. 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 subject at
greater 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 intestinal
obstruction, or internal hernias or abdominal surgeries that the Investigator believes
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 is of child-bearing potential and does not practice medically
acceptable methods of contraception. 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 illness
which, in the Investigator's opinion, would make it unsafe for the subject to
participate 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 in or
within the last 30 days, a pharmaceutical clinical study

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/12/2024. Questions regarding updates should be directed to the study team contact.