Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Colon Polyps Clinical Trial

Official title:

Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354873
• Other study ID #: 10 002315
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: January 8, 2014
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.

Description:

Information will be collected. Images will be taken.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older

• Presenting for surveillance, screening or diagnostic colonoscopy

• Willingness to provide informed consent

Exclusion Criteria:

• Inability to provided informed consent

• Pregnancy

• Known inflammatory bowel disease

• Personal or family history of polyposis or nonpolyposis syndrome

• Emergency colonoscopy/endoscopy

• Coagulopathy or thrombocytopenia preventing polypectomy

• Procedure indication for acute bleeding or active colitis

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Polyps
• Colonic Polyps
• Polyps

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Olympic Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of In Vivo determination of colorectal polyps histopathology	Compare accuracy of current colonoscope to improved colonoscope for discrimination of polyps as neoplastic versus non-neoplastic. The accuracies of the two approaches will be compared via logistic regression model with the significance of the difference in the accuracies assessed via generalized estimating equation approach to take account of the possible dependence introduced by inclusion of mulitple polyps per patient.	1 year	No
Secondary	Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes.	Estimate the sensitivity and specificity in high definition mode for distinguishing neoplastic from none neoplastic lesions. Sensitivity and specificity will be estimated using the logistic regression approach as above; 95% confidence intervals will be obtained by transforming confidence intervals on the logs odds scale.	1 year	No