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

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ClinicalTrials.gov Identifier: NCT01084629
Recruitment Status : Recruiting
First Posted : March 10, 2010
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic

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
Barrett's Esophagus

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Study Type : Observational
Estimated Enrollment : 150 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 : January 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

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


Contacts
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Contact: Bryan J Linn, BA 507-255-4631 linn.bryan@mayo.edu
Contact: Magdalen A. Clemens 507-255-4631 clemens.magdalen@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Bryan J Linn, BA    507-255-4631    linn.bryan@mayo.edu   
Principal Investigator: Kenneth K Wang, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kenneth K Wang, MD Mayo Clinic Rochester MN

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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 Posted: March 10, 2010    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases