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The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) in Barrett's Esophagus

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01084629
Collaborator
(none)
50
Enrollment
1
Location
72.1
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to assess post ablation, if there are areas of Barrett's mucosa post ablation and to assess the ability of the Fujinon FICE system to detect this, as compared to white light endoscopy. A subgroup will also be compared with laser confocal microscopy

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) for the Detection of Dysplasia in Barrett's Esophagus and in Post Ablation Barrett's Esophagus
    Study Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    Nov 4, 2016
    Actual Study Completion Date :
    Nov 4, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Surveillance Barrett's esophagus

    Patients scheduled for endoscopic surveillance of Barrett's esophagus
    Barrett's esophagus post ablation

    Patients scheduled for surveillance endoscopy who have undergone ablative therapies (PDT, RF ablation) for their Barrett's esophagus

    Outcome Measures

    Primary Outcome Measures

    1. detection of dysplasic areas [during surveillance endoscopy]

      Areas of residual mucosa will be scored for being present, absent or suspicious. The ability of both FICE and white light endoscopy to find areas will be graded on the number of areas found, and the size of the areas estimated at the time of endoscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Visible Barrett's esophagus

    • Scheduled for Surveillance Endoscopy

    • Able to undergo endoscopy

    Exclusion Criteria:

    • Unable to undergo endoscopy

    • Unable to stop blood thinning medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Kenneth K Wang, MD, Mayo Clinic, Rochester, MN

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kenneth K. Wang, Kathy and Russ Van Cleve Professor of Gastroenterology Research, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01084629
    Other Study ID Numbers:
    • 07-006981
    First Posted:
    Mar 10, 2010
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Keywords provided by Kenneth K. Wang, Kathy and Russ Van Cleve Professor of Gastroenterology Research, Mayo Clinic
    Barrett's Esophagus
    Surveillance
    Additional relevant MeSH terms:
    Barrett Esophagus

    Study Results

    No Results Posted as of Dec 15, 2021