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Clinical Trials/NCT01054924
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

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

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
December 2009
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Invendo Medical GmbH

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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