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

Completed

• Conditions: Colorectal Cancer Screening

• Registration Number: NCT01054924
• Lead Sponsor: Invendo Medical GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Last Update Submitted: 2010-01-21
• Study First Posted: 2010-01-22
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Centrum Gastroenterologie Bethanien; 🇩🇪 Frankfurt, Hessen, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany