Confocal Laserscanning Microscopy for Detection of Barretts Esophagus
1 other identifier
interventional
73
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedFirst Posted
Study publicly available on registry
March 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedDecember 24, 2008
December 1, 2008
1.3 years
February 23, 2007
December 23, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technical University of Munichlead
- Charite University, Berlin, Germanycollaborator
- Technische Universität Dresdencollaborator
Study Sites (1)
2nd department of the Medical Clinic of the Technical University Munich
Munich, Bavaria, 81675, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Meining, MD
Technical University Munich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 23, 2007
First Posted
March 21, 2007
Study Start
March 1, 2007
Primary Completion
July 1, 2008
Study Completion
November 1, 2008
Last Updated
December 24, 2008
Record last verified: 2008-12