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

Launched by INVENDO MEDICAL GMBH · Jan 21, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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