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Confocal Laser Endomicroscopy During TransUrethral Resection for Improving BC Diagnosis and Treatment

NCT05273593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-10

No results posted yet for this study

Summary

A prospective monocenter diagnostic accuracy study of Confocal Laser Endomicroscopy (CLE) for Bladder Cancer(BC) to assess two primary objectives:

1. The diagnostic accuracy of flexible probe-based confocal laser endomicroscopy (CLE) compared to histopathology of the resection specimen.
2. The diagnostic accuracy of CLE-based assessment of the surgical radicality of the resection bed (radical vs irradical) in comparison with histopathology of a biopsy of the resection bed.

All patients with a papillary bladder tumor on cystoscopy will be included in this trial.

Conditions

Interventions

DEVICE

Confocal Laser Endomicroscopy (CLE)

Administration of fluorescein, intravesically and intravenously. CLE measurements with flexible and rigid probe of papillary bladder tumour and rigid probe-measurement of resection bed.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • J. R. Oddens, MD, PhD · Staff member of Urology Department

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2021-11-12
Completion
2021-11-12

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273593 on ClinicalTrials.gov