MedTrace Logo

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

NCT02313662 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 153

Last updated 2015-12-29

No results posted yet for this study

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.

Conditions

  • Narrow Band Imaging and PDD in Cystoscopy

Interventions

DEVICE

NBI and PDD

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Hospitalsenheden Vest

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Jørgen Bjerggaard Jensen · University of Aarhus

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Denmark
  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313662 on ClinicalTrials.gov