Bladder Cancer Clinical Trial
Official title:
Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department.
Verified date | May 2017 |
Source | University Hospital Bispebjerg and Frederiksberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 21 |
Est. completion date | March 1, 2017 |
Est. primary completion date | February 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Recurrence of pTa low grade urothelial bladder tumor - Tumor < 1.5 cm - < 6 tumors Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Urological department, Frederiksberg Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Gregers Gautier Hermann |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 month |
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