Narrow Band Imaging in Flexible Cystocopy (DaBlaCa-7)

Narrow Band Imaging in Flexible Cystocopy - DaBlaCa-7

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.

Study Overview

• Status: Completed
• Conditions: Narrow Band Imaging in Flexible Cystoscopy

• Study Type: Observational
• Enrollment (Actual): 955

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark
    • Herlev Hospital
  • Holstebro, Denmark
    • Hospitalsenheden Vest
  • Århus N, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

Description

Inclusion Criteria:

• Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

Exclusion Criteria:

• Patients not fullfilling the above

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in the clinical decision	Baseline

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Oslo University Hospital; Herlev Hospital; Hospitalsenheden Vest
• Investigators: Principal Investigator: Jørgen Bjerggaard Jensen, DMSc, University of Aarhus

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimated): December 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DaBlaCa-7