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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01054924

Enrollment

Unknown

Registered

2010-01-22

Start date

2009-11-30

Completion date

2009-12-31

Last updated

2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Countries

Germany

Outcome results