Condition category
Cancer
Date applied
02/07/2009
Date assigned
30/11/2009
Last edited
30/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gregers G Hermann

ORCID ID

Contact details

Department of Urology
Ndr Fasanvej 57
Frederiksberg
Copenhagen
DK-2000
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Method development II

Study information

Scientific title

PhotoDynamic Diagnosis (PDD) and results of biopsies in flexible cystoscopy of bladder tumour patients in an Out-Patient Department set up: a quality assurance study

Acronym

PDD in OPD

Study hypothesis

The study was carried out to develop a method for photodynamic diagnosis (PDD) and bladder biopsies in flexible cystoscopes in the out-patient department (OPD). PDD in the operating theatre and cystoscopy and biopsy using flexible cystoscopes are routine methods in urology departments. The issue was to evaluate them for use in the OPD and to see the quality of biopsies obtained through the scopes. The examinations were performed to see whether we got a usable procedure for a subsequent study comparing the method in OPD and in the operating theatre during admittance to the ward.

Ethics approval

The Danish Medicines Agency (Danish FDA) and the Ethical Committee in Copenhagen feel that there isn't a need to evaulate this study as the methods are commonly used.

Study design

Quality assurance, non-randomised single arm pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Non-muscle invasive bladder tumour

Intervention

Instillation of 50 cc fluorescent material in to the bladder 1 hour before cystoscopy. The instillation gives no side effects. Each treatment last for 15 - 30 minutes and there is no follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Acceptable view in the bladder, measured immediately during the cystoscopy

Secondary outcome measures

Sufficient biopsy information for a valid diagnosis, assessed a few days after cystoscopy where the pathologist give the histological description of the biopsy

Overall trial start date

09/04/2008

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients booked for flexible cystoscopy due to follow up of recurrent bladder tumour according to the guidelines of the ward
2. Aged 54 - 91 years, either sex

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

37

Participant exclusion criteria

1. Patients refuse
2. Non-recurrent bladder tumour disease
3. Pregnancy
4. Aged less than 18 years

Recruitment start date

09/04/2008

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Denmark

Trial participating centre

Department of Urology
Copenhagen
DK-2000
Denmark

Sponsor information

Organisation

Frederiksberg Hospital (Denmark)

Sponsor details

c/o Consultant Urologist Gregers G Hermann
Department of Urology
Copenhagen University
Ndr. Fasanvej 57
Frederiksberg
Copenhagen
DK-2700
Denmark

Sponsor type

Hospital/treatment centre

Website

http://www.frederiksberghospital.dk/menu/Afdelinger/Urologisk+klinik/UrologiskKlinik.htm

Funders

Funder type

Charity

Funder name

The Foundation Juchum (Denmark) - provided financial support

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Boemske Foundation (Denmark) - provided financial support

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Karl Storz, Tuttlingen (Germany) - kindly delivered flexible cystoscope systems

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Richard Wolf GmbH (Germany) - kindly delivered flexible cystoscope systems

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes