Confocal Endomicroscopy for GI Neoplasia Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01515514
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : May 17, 2013
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic

Brief Summary:
The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard "free-hand" image acquisition.

Condition or disease
Colorectal Polyps

Detailed Description:
The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Endomicroscopy for GI Neoplasia Study
Study Start Date : August 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Primary Outcome Measures :
  1. Quality of the confocal image [ Time Frame: 1 yr ]
    Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 40 patients with polyps

Inclusion Criteria:

  • Those patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study.

Exclusion Criteria:

  • Patients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01515514

United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Michael B Wallace, MD,MPH Mayo Clinic Florida

Responsible Party: Michael Wallace, Primary Investigator, Mayo Clinic Identifier: NCT01515514     History of Changes
Other Study ID Numbers: 11-006327
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by Michael Wallace, Mayo Clinic:
inflammatory bowel disease
associated neoplasia

Additional relevant MeSH terms: