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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054924
First Posted: January 22, 2010
Last Update Posted: January 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Invendo Medical GmbH
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01054924     History of Changes
Other Study ID Numbers: INV2009-01
First Submitted: January 21, 2010
First Posted: January 22, 2010
Last Update Posted: January 22, 2010
Last Verified: January 2010

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