Comparison of White Light, PDD and NBI in Detection of Fl... | NCT02313662

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

NCT02313662

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Dec 29, 2015Estimated

Enrollment

153Actual

Phase

Not provided

Conditions

Narrow Band Imaging and PDD in Cystoscopy

Interventions

NBI and PDD

Countries

Denmark
Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Dec 8, 2014

First Submission Date that Met QC Criteria

Dec 9, 2014

First Posted Date

Dec 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2015

Last Update Posted Date

Dec 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jørgen Bjerggaard Jensen, Professor, Aarhus University HospitalPrincipal Investigator

Lead Sponsor

Aarhus University HospitalOTHER

Collaborators

Name	Class
Herlev Hospital	OTHER
Hospitalsenheden Vest	OTHER
Oslo University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Name	Type	Description	Arm Group Labels	Other Names
NBI and PDD	Device

Measure	Description	Time Frame
Detection of CIS		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing PDD according to the Danish guidelines

Exclusion Criteria:

Patients not fulfilling the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing PDD according to the Danish guidelines

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jørgen Bjerggaard Jensen	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus			Denmark
Herlev Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D062048	Narrow Band Imaging

Ancestor Terms

ID	Term
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided