Barrett's EsophagusNCT01360801
High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
An observational study of Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators seek to test the hypothesis that the improved version of high definition white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments than current versions of these endoscopes. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2014
- 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 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women (not pregnant) presenting to the GI Lab for Upper Endoscopy. Child-bearing potential not excluded.
Who may be able to join
- Age 18 years and older
- Patients with Barrett's esophagus (BE) dysplasia as the original indication for treatment
- Undergoing any type of endoscopic BE resection or ablation treatment including RFA, cryotherapy, photodynamic therapy, or EMR, or combinations of these.
- <1cm of circumferential, peninsular, or island-type BE on prior endoscopy or ablation
- Ability to provide written, informed consent
- Deferral Criteria: This category is for patients in two specific situations, 1) Erosive esophagitis, and, 2) presence of a nodule suspicious for the presence of neoplasia.
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- Erosive esophagitis: patients found to have erosive esophagitis, will be deferred for up to 3 months from their Index study procedure, to permit more aggressive medical therapy to heal the erosive esophagitis. After healing, the Index study procedure will be performed up to 3 months later, and the follow-up endoscopy (and study closure) performed 3 to 6 months after that (total of no more than 9 months).
- Presence of nodule suspicious for neoplasia: for patients found to have such nodular lesions, the Index study procedure will be deferred for 3 months, while Endoscopic Mucosal Resection is performed and subsequently heals.
- Note: Only one deferral per patient is permitted, and this one deferral is allowed only for these specific criteria. The end of the study will be defined by the time of follow-up of the last patient who was not deferred; any deferred patients who have not completed follow-up procedures by that time, may miss their follow-up visit as part of the study. (This is to prevent the possibility of delaying the close of the study due to deferral of a procedure late in the study.)
Who cannot join
- Current participation in another clinical study
- Complete eradication of BE documented by biopsies in 3 or more previous endoscopic procedures performed after resection/ablation
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Pregnancy
- Worse than Grade C erosive esophagitis
- Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (ablation or resection).
Trial locations and contacts
1 site in 1 country.
About this study
The investigators seek to test the hypothesis that the improved version of high definition white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments than current versions of these endoscopes.
Read the detailed description
Information will be collected. Images will be taken.
- Conditions
- Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Agreement Between Imaging and Histology
The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.
Measured: 9 months
Secondary outcomes (1)
Presence of Residual Disease
Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: enrollment moved very slowly which was not anticipated, and, funding issues
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Principal investigator, Herbert C. Wolfsen, Mayo Clinic
- Investigators
- Herbert C. Wolfsen,, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360801
- Sponsor's protocol ID
- 10-003234
- Status last verified
- Apr 2014
- First submitted
- 18 May 2011
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
- ClinicalTrials.gov ID
- NCT01360801
- Acronym / sponsor ID
- 10-003234
- Conditions
- Barrett's Esophagus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: enrollment moved very slowly which was not anticipated, and, funding issues
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 May 2011 (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 investigators seek to test the hypothesis that the improved version of high definition white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments than current versions of these endoscopes.
Detailed description
Information will be collected. Images will be taken.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women (not pregnant) presenting to the GI Lab for Upper Endoscopy. Child-bearing potential not excluded.
Key inclusion criteria (9 listed)
- Age 18 years and older
- Patients with Barrett's esophagus (BE) dysplasia as the original indication for treatment
- Undergoing any type of endoscopic BE resection or ablation treatment including RFA, cryotherapy, photodynamic therapy, or EMR, or combinations of these.
- <1cm of circumferential, peninsular, or island-type BE on prior endoscopy or ablation
- Ability to provide written, informed consent
Key exclusion criteria (6 listed)
- Current participation in another clinical study
- Complete eradication of BE documented by biopsies in 3 or more previous endoscopic procedures performed after resection/ablation
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Pregnancy
- Worse than Grade C erosive esophagitis
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
Accuracy of Agreement Between Imaging and Histology
Time frame: 9 months
The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.
1 secondary outcome
Presence of Residual Disease
Time frame: 9 months
Results and safety
The study was stopped early (reason given: enrollment moved very slowly which was not anticipated, and, funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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.
Herbert C. Wolfsen,, M.D. 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 9 inclusion and 6 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 10 Apr 2014. 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 was stopped early (reason given: enrollment moved very slowly which was not anticipated, and, funding issues). 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?
Accuracy of Agreement Between Imaging and Histology (time frame: 9 months). 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 10 Apr 2014.