Virtual Colonoscopy (VC) for Primary Colorectal Screening

Colorectal Polyps Clinical Trial

Official title:

CT Virtual Colonoscopy for Primary Colorectal Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204867
• Other study ID #: 2004-0104
• 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

• Colorectal Polyps

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