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NCT01054924 Clinical Trial

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

Colorectal Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01054924
Other study ID # INV2009-01
Secondary ID
Status Completed
Phase N/A
First received January 21, 2010
Last updated January 21, 2010
Start date November 2009
Est. completion date December 2009

Study information
Verified date January 2010
Source Invendo Medical GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics CommissionGermany: German Institute of Medical Documentation and Information
Study type Observational

Clinical Trial Summary

The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Centrum Gastroenterologie Bethanien Frankfurt Hessen
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Invendo Medical GmbH

Country where clinical trial is conducted

Germany, 

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