NCT01354873

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

2.6 years

First QC Date

May 16, 2011

Last Update Submit

January 8, 2014

Conditions

Colon Polyps

Keywords

ColonoscopyColon Polyps

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 18 and older
  • Presenting for surveillance, screening or diagnostic colonoscopy
  • Willingness to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael B Wallace, MD,MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 17, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

US(1)