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Clinical Study to Assess the Performance of the Invendo C20 Colonoscope System in Persons Undergoing Colorectal Cancer Screening at Average Risk for CRC


N/A
50 Years
75 Years
Not Enrolling
Both
Colorectal Cancer Screening

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Trial Information

Clinical Study to Assess the Performance of the Invendo C20 Colonoscope System in Persons Undergoing Colorectal Cancer Screening at Average Risk for CRC


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Thomas Roesch, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Hamburg-Eppendorf

Authority:

Germany: Ethics Commission

Study ID:

INV2009-01

NCT ID:

NCT01054924

Start Date:

November 2009

Completion Date:

December 2009

Related Keywords:

  • Colorectal Cancer Screening
  • Colorectal Neoplasms

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