Completed
NCT Number: NCT02313662
Comparison of White Light, PDD and NBI in Detection of Flat Dysplasia and CIS at TURB - a Study of Trimodality
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Aarhus University Hospital, Aarhus, Denmark
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients undergoing PDD according to the Danish guidelines
Exclusion criteria
- Patients not fulfilling the inclusion criteria
Treatment and study plan
Primary outcomes
-
Detection of CIS
Time frame: Baseline
Sponsors and collaborators
Lead sponsor
Aarhus University Hospital
Other
Collaborators
- Herlev Hospital
- Hospitalsenheden Vest
- Oslo University Hospital
Registry information
Official study title
Trimodalitets-studie Hvidt Lys vs. NBI vs. PDD Ved Detektion af Flad Dysplasi og CIS Ved TURB
Acronym: DaBlaCa-8
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Dec 10, 2014
- Registry last updated
- Dec 29, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.