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

Inclusion criteria

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

Exclusion criteria

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