- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01084629
The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) in Barrett's Esophagus
December 13, 2021 updated by: Kenneth K. Wang, Mayo Clinic
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
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Barrett's esophagus
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Surveillance Barrett's esophagus
Patients scheduled for endoscopic surveillance of Barrett's esophagus
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Barrett's esophagus post ablation
Patients scheduled for surveillance endoscopy who have undergone ablative therapies (PDT, RF ablation) for their Barrett's esophagus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection of dysplasic areas
Time Frame: during surveillance endoscopy
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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
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during surveillance endoscopy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth K Wang, MD, Mayo Clinic, Rochester, MN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
November 4, 2016
Study Completion (Actual)
November 4, 2016
Study Registration Dates
First Submitted
March 9, 2010
First Submitted That Met QC Criteria
March 9, 2010
First Posted (Estimate)
March 10, 2010
Study Record Updates
Last Update Posted (Actual)
December 15, 2021
Last Update Submitted That Met QC Criteria
December 13, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-006981
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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