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

Narrow Band Imaging and PDD in Cystoscopy Clinical Trial

— DaBlaCa-8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313662
• Other study ID #: DaBlaCa-8
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: December 28, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing PDD according to the Danish guidelines

Exclusion Criteria:

• Patients not fulfilling the inclusion criteria

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Narrow Band Imaging and PDD in Cystoscopy

Intervention

Device:
• NBI and PDD

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Herlev Hospital	Herlev
Denmark	Hospitalsenheden Vest	Holstebro
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	Herlev Hospital, Hospitalsenheden Vest, Oslo University Hospital

Countries where clinical trial is conducted

Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of CIS		Baseline	Yes