Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

This study has been completed.
Sponsor:
Collaborator:
Olympic Medical
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01354873
First received: May 16, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition
Colon Polyps

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Accuracy of In Vivo determination of colorectal polyps histopathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 556
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Information will be collected. Images will be taken.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men and Women(not pregnant) presenting to the GI lab for colonoscopy. Child bearing potential not excluded.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354873

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Olympic Medical
Investigators
Principal Investigator: Michael B Wallace, MD,MPH Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Michael B Wallace, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01354873     History of Changes
Other Study ID Numbers: 10 002315
Study First Received: May 16, 2011
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Colonoscopy
Colon Polyps

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 29, 2014