- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01054924
Performance Study of the Invendo C20 Colonoscope System in Colorectal Cancer Screening
January 21, 2010 updated by: Invendo Medical GmbH
Clinical Study to Assess the Performance of the Invendo C20 Colonoscope System in Persons Undergoing Colorectal Cancer Screening at Average Risk for CRC
The purpose of the study is to evaluate efficacy (i.e.
reaching the cecum) and safety of the Invendo C20 Colonoscopy System
Study Overview
Status
Completed
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany, 20246
- Universitatsklinikum Hamburg-Eppendorf
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Hessen
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Frankfurt, Hessen, Germany, 60389
- Centrum Gastroenterologie Bethanien
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Asymptomatic persons fulfilling U.S. screening criteria for colorectal cancer of age of 50-75 years
Description
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)
- Clinically significant abnormal screening laboratory findings
- Clinically significant abnormal screening ECG findings
- Drug abuse or alcoholism
- Inability of the screenee to adequately communicate
- Screenees under custodial care
- Participation in a clinical study within the last 30 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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U.S. CRC screening population
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Roesch, Prof., Universitatsklinikum Hamburg-Eppendorf
- Principal Investigator: Nicolas Hoepffner, MD, Centrum Gastroenterologie Bethanien, Frankfurt
- Principal Investigator: Douglas K. Rex, Prof., Indiana University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 21, 2010
First Submitted That Met QC Criteria
January 21, 2010
First Posted (Estimate)
January 22, 2010
Study Record Updates
Last Update Posted (Estimate)
January 22, 2010
Last Update Submitted That Met QC Criteria
January 21, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INV2009-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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