NCT01054924

Completed

Performance Study of the Invendo C20 Colonoscope System in C...

Invendo Medical GmbH Source

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Other study identifiers

Sponsor study identifier

INV2009-01

Study Type

observational

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

2

Timeline

Study Start

November 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2009

Actual (reported)

Study Completion

December 2009

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: December 2009
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)
Study Completion
December 2009
Actual (reported)
First Submitted
January 21, 2010
Actual (reported)
First Posted
January 22, 2010
Actual (reported)

Last Updated: January 22, 2010
Status Verified: January 2010
Last Update Submitted: January 21, 2010

Conditions

Colorectal Cancer Screening

Study Arms (1)

U.S. CRC screening population

Eligibility Criteria

Age50 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
Age between 50-75 years
Signed informed consent

You may not qualify if:

Family or personal history of colorectal neoplasia including familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer

Sponsors & Collaborators

Invendo Medical GmbH
Industrylead

Study Sites (2)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Centrum Gastroenterologie Bethanien

Frankfurt am Main, Hesse, 60389, Germany

Study Officials

Thomas Roesch, Prof.
Universitätsklinikum Hamburg-Eppendorf
PRINCIPAL INVESTIGATOR
Nicolas Hoepffner, MD
Centrum Gastroenterologie Bethanien, Frankfurt
PRINCIPAL INVESTIGATOR
Douglas K. Rex, Prof.
Indiana University Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

November 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2009

Actual (reported)

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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

+1 more criteria

Contact the study team to confirm eligibility.

Study Completion

December 2009

Actual (reported)

Last Updated

January 22, 2010

Record last verified: 2010-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01054924
Data provider: ClinicalTrials.gov
Source updated: 2010-01-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:36 UTC

Locations

DE(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Study Arms (1)

U.S. CRC screening population

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Study Design

Study Record Dates

Source record

Locations