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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:
ClinicalTrials.gov Identifier:
NCT01084629
First Posted: March 10, 2010
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
  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:


Further study details as provided by Kenneth K. Wang, Mayo Clinic:

Primary Outcome Measures:
  • detection of dysplasic areas [ Time Frame: 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


Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084629


Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic Rochester MN
  More Information

Responsible Party: Kenneth K. Wang, Kathy and Russ Van Cleve Professor of Gastroenterology Research, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01084629     History of Changes
Other Study ID Numbers: 07-006981
First Submitted: March 9, 2010
First Posted: March 10, 2010
Last Update Posted: August 3, 2017
Last Verified: August 2017

Keywords provided by Kenneth K. Wang, Mayo Clinic:
Barrett's Esophagus
Surveillance

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