Clinical trial · Interventional
The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia
The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
NCT02841904CI-TRIAL-00031936unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal LASER Endomicroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- CLE
- description
- CLE assessed by the pathologist
- interventionNames
- Device: Confocal LASER Endomicroscopy
- type
- ACTIVE_COMPARATOR
- label
- Biopsy
- description
- Histology assessed by the pathologist
- interventionNames
- Device: Confocal LASER Endomicroscopy
Primary outcomes (2)
- measure
- accordance between CLE and histology in flat bladder tumors
- timeFrame
- An average of 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * First time Transurethral Resection of Bladder (TURB) for bladder tumors under 3 cm * Suspicious mucosa / Carcinoma in situ * Recurrent pTa * Positive cytology with normal flexible cystoscopy * Control after Bacille Calmette Guérin (BCG) treatment Exclusion Criteria: * Allergy to fluorescein * Pregnant and lactating women. * Renal failure (eGFR \<20 ml / min)
References
Publications (0)
Data not yet available
No reference posted for this study.