NCT01054924
Completed
Not Applicable
Clinical Study to Assess the Performance of the Invendo C20 Colonoscope System in Persons Undergoing Colorectal Cancer Screening at Average Risk for CRC
Invendo Medical GmbH2 sites in 1 countryNovember 2009
ConditionsColorectal Cancer Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer Screening
- Sponsor
- Invendo Medical GmbH
- Locations
- 2
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System
Investigators
Eligibility Criteria
Inclusion Criteria
- •Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
- •Age between 50-75 years
- •Signed informed consent
Exclusion Criteria
- •Family or personal history of colorectal neoplasia including familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer
- •Prior colonoscopy within preceding 10 years
- •A suspected diagnosis of inflammatory bowel disease, bowel obstruction, acute diverticulitis, known severe diverticulosis or any known large bowel disease
- •Clinically significant cardiovascular or pulmonary diseases
- •Gastrointestinal-tract related symptoms, complaints or diseases suggesting performance of colonoscopy (no screening cases)
- •Cancer or other life threatening diseases or significant chronic conditions
- •Blood clotting disorders and /or anti-coagulant therapy including aspirin within the last 7 days
- •Known pregnancy or positive screening pregnancy tests
- •Previous abdominal surgery except for uncomplicated cholecystectomy, appendectomy or minor pelvic surgery (e.g. hernia repair, oophorectomy)
- •Morbid obesity (BMI \> 40)
Outcomes
Primary Outcomes
Not specified
Study Sites (2)
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