Performance Study of the Invendo C20 Colonoscope System in Colorectal Cancer Screening

Asymptomatic persons fulfilling U.S. screening criteria for colorectal cancer of age of 50-75 years

Inclusion Criteria:

1. Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
2. Age between 50-75 years
3. Signed informed consent

Exclusion Criteria:

1. Family or personal history of colorectal neoplasia including familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer
2. Prior colonoscopy within preceding 10 years
3. A suspected diagnosis of inflammatory bowel disease, bowel obstruction, acute diverticulitis, known severe diverticulosis or any known large bowel disease
4. Clinically significant cardiovascular or pulmonary diseases
5. Gastrointestinal-tract related symptoms, complaints or diseases suggesting performance of colonoscopy (no screening cases)
6. Cancer or other life threatening diseases or significant chronic conditions
7. Blood clotting disorders and /or anti-coagulant therapy including aspirin within the last 7 days
8. Known pregnancy or positive screening pregnancy tests
9. Previous abdominal surgery except for uncomplicated cholecystectomy, appendectomy or minor pelvic surgery (e.g. hernia repair, oophorectomy)
10. Morbid obesity (BMI > 40)
11. Clinically significant abnormal screening laboratory findings
12. Clinically significant abnormal screening ECG findings
13. Drug abuse or alcoholism
14. Inability of the screenee to adequately communicate
15. Screenees under custodial care
16. Participation in a clinical study within the last 30 days