NCT02313636

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
955

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

December 8, 2014

Last Update Submit

May 30, 2023

Conditions

Narrow Band Imaging in Flexible Cystoscopy

Outcome Measures

Primary Outcomes (1)

  • change in the clinical decision

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

You may qualify if:

  • Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

You may not qualify if:

  • Patients not fullfilling the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Århus N, 8200, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Hospitalsenheden Vest

Holstebro, Denmark

Location

Study Officials

  • Jørgen Bjerggaard Jensen, DMSc

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2015

Study Completion

November 1, 2015

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

DK(3)