Barrett EsophagusNCT00449995
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus
A study testing confocal laser microscopy in people with Barrett Esophagus, run by Technical University of Munich at 1 site in Germany.
Trial summary
Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- confocal laser microscopy
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Nov 2008
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years
- regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1)
- patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes <1cm
- patients presenting with suspected intraepithelial neoplastic changes
- patients receiving acid suppressive therapy in standard dose for at least 4 weeks
Who cannot join
- no informed consent
- thrombocytopenia, quick <50%, PTT >50 sec
- patients with coronary heart disease or existent valve plasties
- women with potential pregnancy
- patients with chronic renal failure
- patients with allergies
- patients with chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
2nd department of the Medical Clinic of the Technical University Munich
Munich, Bavaria, 81675
About this study
Official title: Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.
Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.
- Conditions
- Barrett Esophagus
- Being tested
- confocal laser 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.
confocal laser microscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus
Secondary outcomes (1)
inter- and intra observer variability for confocal laser scanning microscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Alexander Meining, MD, Principal investigator, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449995
- Sponsor's protocol ID
- 1129/04
- Status last verified
- Dec 2008
- First submitted
- 23 Feb 2007
- Last updated
- 24 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.
- ClinicalTrials.gov ID
- NCT00449995
- Acronym / sponsor ID
- 1129/04
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Technische Universität Dresden
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Mar 2007 (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.
Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 and 80 years
- regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1)
- patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes <1cm
- patients presenting with suspected intraepithelial neoplastic changes
- patients receiving acid suppressive therapy in standard dose for at least 4 weeks
Key exclusion criteria (7 listed)
- no informed consent
- thrombocytopenia, quick <50%, PTT >50 sec
- patients with coronary heart disease or existent valve plasties
- women with potential pregnancy
- patients with chronic renal failure
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 |
|---|---|---|
| confocal laser microscopy | Procedure or surgery | – |
Primary outcome
diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus
1 secondary outcome
inter- and intra observer variability for confocal laser scanning microscopy
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 Dec 2008.
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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.
Alexander Meining, MD principal investigator
Technical University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing confocal laser microscopy in people with Barrett Esophagus, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 7 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 Dec 2008. 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 Germany. 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?
diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus. 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 24 Dec 2008.