Barrett's EsophagusNCT00587184
Confocal Microscopy in Barrett's Esophagus
An observational study of Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
This data review will be done to evaluate the use of confocal microscopy imaging in patients who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts Esophagus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had confocal microscopy imaging in patients at the time of or clinically indicated endoscopic surveillance and biopsies of BE.
Who may be able to join
- Patients who have undergone confocal microscopy at the time of surveillance endoscopy for Barrett's Esophagus
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Confocal Microscopy in Barrett's Esophagus
This data review will be done to evaluate the use of confocal microscopy imaging in patients who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts Esophagus
Read the detailed description
This retrospective chart review will be done to evaluate the use of confocal microscopy imaging in patients who were seen at Mayo Clinic for clinically indicated endoscopic surveillance and biopsies of BE.
Endoscopy reports and pathology results will be reviewed from 100 patients who have undergone endoscopy. These results will be correlated with images obtained with confocal microscopy at the time of the endoscopy. There will be no patient contact.
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Confocal Microscopy
- 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 |
|---|---|---|
| 1 | patients who were seen clinically indicated endoscopic surveillance and biopsies of BE and confocal microscopy was performed. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJul 2006
- Primary completionFeb 2013
- Study completionMar 2013
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
- Retrospective
- Enrolment
- 92 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587184
- Sponsor's protocol ID
- 06-004664
- Status last verified
- Nov 2013
- First submitted
- 21 Dec 2007
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Confocal Microscopy in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT00587184
- Acronym / sponsor ID
- 06-004664
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Confocal Microscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Jan 2008 (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.
This data review will be done to evaluate the use of confocal microscopy imaging in patients who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts Esophagus
Detailed description
This retrospective chart review will be done to evaluate the use of confocal microscopy imaging in patients who were seen at Mayo Clinic for clinically indicated endoscopic surveillance and biopsies of BE.
Endoscopy reports and pathology results will be reviewed from 100 patients who have undergone endoscopy. These results will be correlated with images obtained with confocal microscopy at the time of the endoscopy. There will be no patient contact.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients who were seen clinically indicated endoscopic surveillance and biopsies of BE and confocal microscopy was performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had confocal microscopy imaging in patients at the time of or clinically indicated endoscopic surveillance and biopsies of BE.
Key inclusion criteria (1 listed)
- Patients who have undergone confocal microscopy at the time of surveillance endoscopy for Barrett's Esophagus
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 24 Nov 2015.
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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
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 1 inclusion and 0 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 24 Nov 2015. 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.
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 24 Nov 2015; AzTrials last refreshed its copy on 5 Nov 2026.