Bladder CancerNCT02738827
Diode Laser Treatment of Bladder Tumors
A study testing Laser treatment in people with Bladder Cancer, run by Gregers Gautier Hermann at 1 site in Denmark.
Trial summary
Laser treatment of pTa low grade bladder tumours in the outpatient department Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrence of pTa low grade urothelial bladder tumor
- Tumor < 1.5 cm
- < 6 tumors
Who cannot join
- Patients with porphyria
- Known hypersensitivity to Hexvix® or porphyrins
- Use of any anticoagulants
- Macroscopic hematuria
- Pregnant or breast feeding women
- Expected poor compliance
- Patients < 18 years
- Patients who do not read or understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department.
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
Read the detailed description
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
Study Design: Open prospective study in patients with recurrent pTa low grade bladder tumours.
All patients will have their bladder tumour removed using a diode laser. The treatment will take place in the outpatient department (OPD) without any pain treatment. Biopsy from the tumour will be obtained before the procedure. If the biopsy shows low grade non-invasive bladder tumour, flexible cystoscopy will be repeated one month later in the OPD. At both procedures biopsy will be taken from the laser treated area.
If the per-operative biopsy shows high grade or invasive tumour, the patient will be referred for a re-resection at the operating theatre during admittance to the urology ward.
The pain is valuated by a Visual Analogue Scale Score and filled out immediately after each procedure.
Treatment induced symptoms will be evaluated using a QOL questionnaire which the patient fills out one week after the laser treatment and one week after the cystoscopies.
Population: Patients with histologically confirmed pTa urothelial bladder tumours Number of Subjects: Twenty patients Selection of Subjects: Patients scheduled for a trans urethral resection of bladder tumour (TUR-B) less than 1,5 cm at the operating theatre under general anaesthesia and without concomitant therapy with anticoagulants as Marevan, Marcoumar, and the new anticoagulants as Pradaxa etc. will after informed consent be included in the study.
Equipment:
Diode laser Storz, SPIES Biopsy forceps, Storz
Key Dates:
Overall duration of the study: 6 months included 1 months follow up Efficacy and Safety Variables Primary Endpoint: proportion of patients where the bladder tumours are completely removed by one laser treatment.
Secondary Endpoints:
- Portion of general urinary problems and QOL after laser treatment compared to cystoscopy and biopsy in the OPD
- Pain at the laser treatment and the cystoscopy assessed by Visual Analog Scale (VAS) Score.
Statistical Methods and Planned Analysis: Non-parametric and descriptive statistics will be performed
Parameters in the case report form (CRF):
Bladder cancer diagnosis (pTa low grade)
- Age
- Sex
- Mapping of lesions in normal, Clara Chrome, Spectra A and B filter cystoscopy
- Histology of all suspicious lesions
- SEPARATE CYSTOSCOPYFORM for laser TUR-B and the two follow up cystoscopies
- The duration of the laser treatment
- Expected clearance after the laser TUR-B
- The visibility during the laser TUR-B
- Visual Analog Scale Score result (to measure pain when laser treatment is performed and biopsies are taken in the OPD)
- Conditions
- Bladder Cancer
- Being tested
- Laser treatment
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentProcedure or surgery
Intervention is diode laser treatment of bladder cancer through a cystoscope in the outpatient department
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Other | Intervention is diode laser treatment of bladder cancer through a cystoscope without sedation of the patient. Receives: Procedure: Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour clearance
No bladder tumor tissue in biopsies obtained from areas where a bladder tumor one month earlier has been removed by use of diode laser.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startNov 2015
- Primary completion1 Feb 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregers Gautier Hermann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gregers Gautier Hermann, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Gregers G Hermann, MD, Principal investigator, Dept Urology, Herlev/Gentofte hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738827
- Sponsor's protocol ID
- URU05
- Status last verified
- May 2017
- First submitted
- 21 Dec 2015
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department.
- ClinicalTrials.gov ID
- NCT02738827
- Acronym / sponsor ID
- URU05
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Gregers Gautier HermannUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
Detailed description
Laser treatment of pTa low grade bladder tumours in the outpatient department
Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
Study Design: Open prospective study in patients with recurrent pTa low grade bladder tumours.
All patients will have their bladder tumour removed using a diode laser. The treatment will take place in the outpatient department (OPD) without any pain treatment. Biopsy from the tumour will be obtained before the procedure. If the biopsy shows low grade non-invasive bladder tumour, flexible cystoscopy will be repeated one month later in the OPD. At both procedures biopsy will be taken from the laser treated area.
If the per-operative biopsy shows high grade or invasive tumour, the patient will be referred for a re-resection at the operating theatre during admittance to the urology ward.
The pain is valuated by a Visual Analogue Scale Score and filled out immediately after each procedure.
Treatment induced symptoms will be evaluated using a QOL questionnaire which the patient fills out one week after the laser treatment and one week after the cystoscopies.
Population: Patients with histologically confirmed pTa urothelial bladder tumours Number of Subjects: Twenty patients Selection of Subjects: Patients scheduled for a trans urethral resection of bladder tumour (TUR-B) less than 1,5 cm at the operating theatre under general anaesthesia and without concomitant therapy with anticoagulants as Marevan, Marcoumar, and the new anticoagulants as Pradaxa etc. will after informed consent be included in the study.
Equipment:
Diode laser Storz, SPIES Biopsy forceps, Storz
Key Dates:
Overall duration of the study: 6 months included 1 months follow up Efficacy and Safety Variables Primary Endpoint: proportion of patients where the bladder tumours are completely removed by one laser treatment.
Secondary Endpoints:
- Portion of general urinary problems and QOL after laser treatment compared to cystoscopy and biopsy in the OPD
- Pain at the laser treatment and the cystoscopy assessed by Visual Analog Scale (VAS) Score.
Statistical Methods and Planned Analysis: Non-parametric and descriptive statistics will be performed
Parameters in the case report form (CRF):
Bladder cancer diagnosis (pTa low grade)
- Age
- Sex
- Mapping of lesions in normal, Clara Chrome, Spectra A and B filter cystoscopy
- Histology of all suspicious lesions
- SEPARATE CYSTOSCOPYFORM for laser TUR-B and the two follow up cystoscopies
- The duration of the laser treatment
- Expected clearance after the laser TUR-B
- The visibility during the laser TUR-B
- Visual Analog Scale Score result (to measure pain when laser treatment is performed and biopsies are taken in the OPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Other | Procedure: Laser treatmentIntervention is diode laser treatment of bladder cancer through a cystoscope without sedation of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrence of pTa low grade urothelial bladder tumor
- Tumor < 1.5 cm
- < 6 tumors
Key exclusion criteria (8 listed)
- Patients with porphyria
- Known hypersensitivity to Hexvix® or porphyrins
- Use of any anticoagulants
- Macroscopic hematuria
- Pregnant or breast feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser treatmentIntervention is diode laser treatment of bladder cancer through a cystoscope in the outpatient department | Procedure or surgery | Laser treatment |
Primary outcome
Tumour clearance
Time frame: 1 month
No bladder tumor tissue in biopsies obtained from areas where a bladder tumor one month earlier has been removed by use of diode laser.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregers G Hermann, MD principal investigator
Dept Urology, Herlev/Gentofte hospital, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Bladder Cancer, run by Gregers Gautier Hermann at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour clearance (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.