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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
History of Changes
  Purpose

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
Colorectal Polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Endomicroscopy for GI Neoplasia Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

  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

Approximately 40 patients with polyps

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515514

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

No publications provided

Responsible Party: Michael Wallace, Primary Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01515514     History of Changes
Other Study ID Numbers: 11-006327
Study First Received: January 10, 2012
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
polyps
inflammatory bowel disease
associated neoplasia

Additional relevant MeSH terms:
Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Polyps
Colonic Polyps
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Pathological Conditions, Anatomical
Intestinal Polyps

ClinicalTrials.gov processed this record on May 16, 2013