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NCT01515514 Clinical Trial

Confocal Endomicroscopy for GI Neoplasia Study

Colorectal Polyps Clinical Trial

Official title:
Confocal Endomicroscopy for GI Neoplasia Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01515514
Other study ID # 11-006327
Secondary ID
Status Completed
Phase N/A
First received January 10, 2012
Last updated May 15, 2013
Start date August 2012
Est. completion date November 2012

Study information
Verified date May 2013
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Florida Jacksonville Florida

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Bankhead-Coley

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of the confocal image Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts. 1 yr No
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