A Study to Evaluate the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps Compared to Colonoscopy
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 20-007951
- Scottsdale/Phoenix, Arizona: 20-007951
NCT ID: NCT04607746
Sponsor Protocol Number: CLN-CVI-5794
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).
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.
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
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
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
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.
Publications are currently not available