Colorectal Cancer ScreeningNCT01054924
Performance Study of the Invendo C20 Colonoscope System in Colorectal Cancer Screening
An observational study of Colorectal Cancer Screening, run by Invendo Medical GmbH at 2 sites in Germany.
Trial summary
The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- How many people
- Not given
- Where
- 2 sitesGermany
- Study dates
- Nov 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomatic persons fulfilling U.S. screening criteria for colorectal cancer of age of 50-75 years
Who may be able to join
- Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
- Age between 50-75 years
- Signed informed consent
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Centrum Gastroenterologie Bethanien
Frankfurt am Main, Hesse, 60389
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
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
The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System
- Conditions
- Colorectal Cancer Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| U.S. CRC screening population | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Invendo Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Roesch, Prof., Principal investigator, Universitätsklinikum Hamburg-EppendorfNicolas Hoepffner, MD, Principal investigator, Centrum Gastroenterologie Bethanien, FrankfurtDouglas K. Rex, Prof., Principal investigator, Indiana University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054924
- Sponsor's protocol ID
- INV2009-01
- Status last verified
- Jan 2010
- First submitted
- 21 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01054924
- Acronym / sponsor ID
- INV2009-01
- Conditions
- Colorectal Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Invendo Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. CRC screening population | – | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic persons fulfilling U.S. screening criteria for colorectal cancer of age of 50-75 years
Key inclusion criteria (3 listed)
- Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
- Age between 50-75 years
- Signed informed consent
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Roesch, Prof. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Nicolas Hoepffner, MD principal investigator
Centrum Gastroenterologie Bethanien, Frankfurt
Douglas K. Rex, Prof. principal investigator
Indiana University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Screening, run by Invendo Medical GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2010.