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

I

Invendo Medical

Status

Completed

Conditions

Colorectal Cancer Screening

Study type

Observational

Funder types

Industry

Identifiers

NCT01054924
INV2009-01

Details and patient eligibility

About

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

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

0 participants in 1 patient group

U.S. CRC screening population

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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