Confocal Laser Endomicroscopy before transurethral resection for optimizing Bladder Cancer diagnosis and treatment.

Confocal Laser Endomicroscopy before transurethral resection for optimizing Bladder Cancer diagnosis and treatment. - CLETUR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55286

Enrollment

Registered

2019-11-18

Start date

2020-01-06

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer urothelial carcinoma of the bladder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - papillary bladder cancer - 18 years or older - bladder that is accessible transurethral for cystoscopic follow up.

Exclusion criteria

Exclusion criteria: - allergy for fluorescein

Design outcomes

Primary

Measure	Time frame
1. Overall accuracy, sensitivity and specificity of flexible probe CLE-based diagnosis (benign vs malignant) and grading (low-grade versus high-grade) in comparison with the histopathology of the resection specimen. 2. Overall accuracy, sensitivity and specificity of CLE-based assessment of the surgical radicality of the resection bed (radical versus irradical) in comparison with the histopathology of the biopsy of the resection bed.	—

Measure

Time frame

1. Overall accuracy, sensitivity and specificity of flexible probe CLE-based diagnosis (benign vs malignant) and grading (low-grade versus high-grade) in comparison with the histopathology of the resection specimen. 2. Overall accuracy, sensitivity and specificity of CLE-based assessment of the surgical radicality of the resection bed (radical versus irradical) in comparison with the histopathology of the biopsy of the resection bed.

—

Secondary

Measure	Time frame
- Diagnostic accuracy of computer aided diagnosis based on CLE images compared to histopathology.	—

Countries

Netherlands

Outcome results