Confocal Endomicroscopy for GI Neoplasia Study

This study has been completed.
Sponsor:
Collaborator:
Bankhead-Coley
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01515514
First received: January 10, 2012
Last updated: May 15, 2013
Last verified: May 2013

January 10, 2012
May 15, 2013
August 2012
November 2012   (final data collection date for primary outcome measure)
Quality of the confocal image [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.
Quality of the confocal image [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts (Drs. Wallace and Picco) blinded to both the image acquisition method, and the other evaluators rating as previously reported using histology as a reference standard (1-5 scale with 1-worst, 3- acceptable, 5- equal to histology).
Complete list of historical versions of study NCT01515514 on ClinicalTrials.gov Archive Site
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Confocal Endomicroscopy for GI Neoplasia Study
Confocal Endomicroscopy for GI Neoplasia Study

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Approximately 40 patients with polyps

Colorectal Polyps
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01515514
11-006327
No
Michael Wallace, Mayo Clinic
Mayo Clinic
Bankhead-Coley
Principal Investigator: Michael B Wallace, MD,MPH Mayo Clinic Florida
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP