NCT02313662

Comparison of White Light, PDD and NBI in Detection of Flat Dysplasia and CIS at TURB - a Study of Trimodality

Trimodalitets-studie Hvidt Lys vs. NBI vs. PDD Ved Detektion af Flad Dysplasi og CIS Ved TURB

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

All patients planned for PDD guided TURB can be included in this study. Two different optics with PDD and NBI are applied to the resectoscope in addition to regular WL. First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with registration of any additional findings. To adjust for bias introduced by photo bleaching, the second part of the study will be performed with PDD as the second modality. Any flat lesions will be biopsied if they appear suspicious in one of the modalities. The registration form is completed by the surgeon, once the pathology results are known. A total number of 152 patients is planned to be included.

Conditions

• Narrow Band Imaging and PDD in Cystoscopy

Interventions

Type	Name	Description
DEVICE	NBI and PDD

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-12-10
• Last updated: 2015-12-29

Locations

4 sites across 2 countries: Denmark, Norway