A Study to Evaluate the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps Compared to Colonoscopy

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is anticipated that the data from this clinical trial will be used to support marketing authorizations to commercialize the CapsoCam® Colon (CV-3).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. Uncompensated 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, or participated in within the last 30 days, another
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 8/19/22. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Rajan, M.D.

Open for enrollment

Contact information:

Crystal Lavey CCRP

(507) 538-1361

Lavey.Crystal@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jonathan Leighton, M.D.

Open for enrollment

Contact information:

Samantha Basch

(480) 301-6586

Basch.Samantha@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions