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

This study has been completed.
Sponsor:
Information provided by:
Invendo Medical GmbH
ClinicalTrials.gov Identifier:
NCT01054924
First received: January 21, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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


Condition
Colorectal Cancer Screening

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Study to Assess the Performance of the Invendo C20 Colonoscope System in Persons Undergoing Colorectal Cancer Screening at Average Risk for CRC

Resource links provided by NLM:


Further study details as provided by Invendo Medical GmbH:

Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
U.S. CRC screening population

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Asymptomatic persons fulfilling U.S. screening criteria for colorectal cancer of age of 50-75 years

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054924

Locations
Germany
Centrum Gastroenterologie Bethanien
Frankfurt, Hessen, Germany, 60389
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Invendo Medical GmbH
Investigators
Principal Investigator: Thomas Roesch, Prof. Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Nicolas Hoepffner, MD Centrum Gastroenterologie Bethanien, Frankfurt
Principal Investigator: Douglas K. Rex, Prof. Indiana University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01054924     History of Changes
Other Study ID Numbers: INV2009-01
Study First Received: January 21, 2010
Last Updated: January 21, 2010
Health Authority: Germany: Ethics Commission
Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014