Barrett's EsophagusNCT01084629
The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) in Barrett's Esophagus
An observational study of Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 4 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Barrett's esophagus
Who may be able to join
- Visible Barrett's esophagus
- Scheduled for Surveillance Endoscopy
- Able to undergo endoscopy
Who cannot join
- Unable to undergo endoscopy
- Unable to stop blood thinning medications
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Surveillance
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of dysplasic areas
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
Measured: during surveillance endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startNov 2010
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth K. Wang, Mayo Clinic
- Investigators
- Kenneth K Wang, MD, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084629
- Sponsor's protocol ID
- 07-006981
- Status last verified
- Dec 2021
- First submitted
- 9 Mar 2010
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01084629
- Acronym / sponsor ID
- 07-006981
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Barrett's esophagus
Key inclusion criteria (3 listed)
- Visible Barrett's esophagus
- Scheduled for Surveillance Endoscopy
- Able to undergo endoscopy
Key exclusion criteria (2 listed)
- Unable to undergo endoscopy
- Unable to stop blood thinning medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Barrett's Esophagus
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth K Wang, MD principal investigator
Mayo Clinic, Rochester, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of dysplasic areas (time frame: during surveillance endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.