NCT02313662

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
2 countries

4 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

December 1, 2014

Completed
7 days 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
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

December 8, 2014

Last Update Submit

December 28, 2015

Conditions

Narrow Band Imaging and PDD in Cystoscopy

Outcome Measures

Primary Outcomes (1)

  • Detection of CIS

    Baseline

Interventions

NBI and PDDDEVICE

Eligibility Criteria

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

Patients undergoing PDD according to the Danish guidelines

You may qualify if:

  • Patients undergoing PDD according to the Danish guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aarhus University Hospital

Aarhus, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Hospitalsenheden Vest

Holstebro, Denmark

Location

Oslo University Hospital

Oslo, 0275, Norway

Location

MeSH Terms

Interventions

Narrow Band Imaging

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Jørgen Bjerggaard Jensen

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
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

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

DK(3)NO(1)