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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02313662

Acronym

DaBlaCa-8

Enrollment

153

Registered

2014-12-10

Start date

2014-12-31

Completion date

2015-10-31

Last updated

2015-12-29

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

Conditions

Narrow Band Imaging and PDD in Cystoscopy

Brief 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.

Interventions

DEVICENBI and PDD

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing PDD according to the Danish guidelines

Exclusion criteria

* Patients not fulfilling the inclusion criteria

Design outcomes

Primary

Measure	Time frame
Detection of CIS	Baseline

Countries

Denmark, Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026