Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

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.

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Key information

Conditions

Colon Polyps Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

Information will be collected. Images will be taken.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Accuracy of In Vivo determination of colorectal polyps histopathology

Time frame: 1 year

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.

Secondary outcomes

Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes.

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Olympic Medical

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: May 17, 2011
Registry last updated: Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed