Barrett's EsophagusPhase 4NCT01030263
A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies
A Phase 4 study testing Fluorescence-aided confocal endomicroscopy guided biopsy. and Random four-quadrant biopsies. in people with Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Fluorescence-aided confocal endomicroscopy guided biopsy. and Random four-quadrant biopsies.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Mar 2010
- Phase
- Phase 4
- 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
Who may be able to join
- Age at least 18.
- Barrett's esophagus
- Acid suppressive therapy
- Endoscopic surveillance
Who cannot join
- Pregnancy or lactation
- Allergy to fluorescein
- Endoscopic esophagitis Los Angeles classification A to D
- Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion
- Obvious mass lesions or cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies With Random Biopsies in the Detection of Specialized Columnar Epithelium in Barrett's Esophagus
We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.
- Conditions
- Barrett's Esophagus
- Being tested
- Fluorescence-aided confocal endomicroscopy guided biopsy., Random four-quadrant biopsies.
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence-aided confocal endomicroscopy guided biopsy.Other
Fluorescence-aided confocal endomicroscopy guided biopsy.
Random four-quadrant biopsies.Other
Random four-quadrant biopsies.
| Study group | Role | What they receive |
|---|---|---|
| CEM | Experimental | Biopsies obtained with fluorescence-aided confocal endomicroscopy. Receives: Other: Fluorescence-aided confocal endomicroscopy guided biopsy. |
| RFQ | Other | Random four-quadrant biopsies. Receives: Other: Random four-quadrant biopsies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether specialized columnar epithelium was detected.
Measured: At biopsy on Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: The investigators left the institution.
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Ananya Das, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030263
- Sponsor's protocol ID
- 08-001090
- Status last verified
- Mar 2010
- First submitted
- 7 Dec 2009
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies With Random Biopsies in the Detection of Specialized Columnar Epithelium in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT01030263
- Acronym / sponsor ID
- 08-001090
- Conditions
- Barrett's Esophagus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The investigators left the institution.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Dec 2009 (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.
We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEM | Experimental | Other: Fluorescence-aided confocal endomicroscopy guided biopsy.Biopsies obtained with fluorescence-aided confocal endomicroscopy. |
| RFQ | Other | Other: Random four-quadrant biopsies.Random four-quadrant biopsies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age at least 18.
- Barrett's esophagus
- Acid suppressive therapy
- Endoscopic surveillance
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Allergy to fluorescein
- Endoscopic esophagitis Los Angeles classification A to D
- Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion
- Obvious mass lesions or cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescence-aided confocal endomicroscopy guided biopsy.Fluorescence-aided confocal endomicroscopy guided biopsy. | Other | CEM |
| Random four-quadrant biopsies.Random four-quadrant biopsies. | Other | RFQ |
Primary outcome
Whether specialized columnar epithelium was detected.
Time frame: At biopsy on Day 0.
Results and safety
The study was stopped early (reason given: The investigators left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
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.
Ananya Das, 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?
A Phase 4 study testing Fluorescence-aided confocal endomicroscopy guided biopsy. and Random four-quadrant biopsies. in people with 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Mar 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The investigators left the institution.). Results are not available in the source record.
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?
Whether specialized columnar epithelium was detected. (time frame: At biopsy on Day 0.). 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 25 Mar 2010.