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

NCT ID: NCT02313662

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Narrow Band Imaging and PDD in Cystoscopy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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NBI and PDD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing PDD according to the Danish guidelines
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role collaborator

Hospitalsenheden Vest

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jørgen Bjerggaard Jensen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jørgen Bjerggaard Jensen

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Herlev Hospital

Herlev, , Denmark

Site Status

Hospitalsenheden Vest

Holstebro, , Denmark

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Denmark Norway

Other Identifiers

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DaBlaCa-8

Identifier Type: -

Identifier Source: org_study_id