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

This study has suspended participant recruitment.
(This voluntary action is being taken by Fujinon in response to an inquiry by the US FDA regarding the potential use of FICE)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01084629
First received: March 9, 2010
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Barrett's Esophagus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • detection of dysplasic areas [ Time Frame: during surveillance endoscopy ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Barrett's esophagus

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084629

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Kenneth K Wang MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01084629     History of Changes
Other Study ID Numbers: 07-006981
Study First Received: March 9, 2010
Last Updated: April 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's Esophagus
Surveillance

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013