The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia
NCT02841904 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189
Last updated 2018-03-06
Summary
This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results.
Conditions
Interventions
- DEVICE
-
Confocal LASER Endomicroscopy
Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.
Sponsors & Collaborators
-
Herlev Hospital
lead OTHER
Principal Investigators
-
Sami Beji, MD · Herlev Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-30
- Primary Completion
- 2019-09-30
- Completion
- 2019-12-31
Countries
- Denmark
Study Locations
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