Narrow Band Imaging in Flexible Cystocopy

NCT ID: NCT02313636

Last Updated: 2023-05-31

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

955 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-11-30

Brief Summary

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Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light sources.

First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical decision is noted.

A total number of 896 patients is planned to be included.

Detailed Description

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Conditions

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Narrow Band Imaging in Flexible Cystoscopy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

Exclusion Criteria

* Patients not fullfilling the above
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, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Aarhus University Hospital

Århus N, , Denmark

Site Status

Herlev Hospital

Herlev, , Denmark

Site Status

Hospitalsenheden Vest

Holstebro, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DaBlaCa-7

Identifier Type: -

Identifier Source: org_study_id

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