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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00204867
Other study ID # 2004-0104
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated June 17, 2016
Start date July 2004
Est. completion date June 2016

Study information

Verified date June 2016
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study involves a primary VC screening for colorectal polyps. The research hypothesis is that VC screening, including surveillance of sub-cm polyps, is a safe and effective approach.


Description:

The purpose of this study is to use virtual colonoscopy screening to learn more about what happens to small colon polyps (less than 10 mm) over time. From this, we can find out whether it's safer to remove all colon polyps right away or leave the small ones in place and remove only those that grow to 10 mm or more.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Medium-sized colorectal polyps (6-9 mm)

Exclusion Criteria:

- No medium-sized colorectal polyps (6-9 mm)

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
CTC surveillance
In vivo CTC surveillance of 6-9 mm polyp

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Naval Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The growth rate (natural history) of small colorectal polyps Polyp growth rates are established by comparing polyp volume at the initial and surveillance CTC studies The outcome measure of polyp growth rate is established at the time of surveillance CTC by comparing to the baseline CTC No
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