PhotoDynamic Diagnosis (PDD) and results of biopsies in flexible cystoscopy of bladder tumour patients in an Out-Patient Department set up
| ISRCTN | ISRCTN88551578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88551578 |
| Secondary identifying numbers | Method development II |
- Submission date
- 02/07/2009
- Registration date
- 30/11/2009
- Last edited
- 30/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gregers G Hermann
Scientific
Scientific
Department of Urology
Ndr Fasanvej 57
Frederiksberg
Copenhagen
DK-2000
Denmark
Study information
| Study design | Quality assurance, non-randomised single arm pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | PDD in OPD |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 09/04/2008 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 37 |
| Key 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 |
| Key exclusion criteria | 1. Patients refuse 2. Non-recurrent bladder tumour disease 3. Pregnancy 4. Aged less than 18 years |
| Date of first enrolment | 09/04/2008 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Urology
Copenhagen
DK-2000
Denmark
DK-2000
Denmark
Sponsor information
Frederiksberg Hospital (Denmark)
Hospital/treatment centre
Hospital/treatment centre
c/o Consultant Urologist Gregers G Hermann
Department of Urology
Copenhagen University
Ndr. Fasanvej 57
Frederiksberg
Copenhagen
DK-2700
Denmark
| Website | http://www.frederiksberghospital.dk/menu/Afdelinger/Urologisk+klinik/UrologiskKlinik.htm |
|---|---|
"ROR" |
https://ror.org/00d264c35 |
Funders
Funder type
Charity
The Foundation Juchum (Denmark) - provided financial support
No information available
Boemske Foundation (Denmark) - provided financial support
No information available
Karl Storz, Tuttlingen (Germany) - kindly delivered flexible cystoscope systems
No information available
Richard Wolf GmbH (Germany) - kindly delivered flexible cystoscope systems
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
