EUCTR2015-000436-15-DKActive, not recruitingPhase 1
Photodynamic diagnosis (PDD) in flexible cystoscopy – a randomized study with focus on significant recurrence
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Aarhus Universitet
- Enrollment
- 696
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •age over 18 years
- •first time TUR-B where the pathology showed Ta ( LG and HG)
- •informed consent on the basis of oral and written information
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 696
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 696
Exclusion Criteria
- •lack of consent
- •communication problems
- •missing or incomplete implementation of the procedure and Hexvix installation
- •active cystitis
- •catheter in the bladder ( chronic)
- •AK treatment apart from aspirin
- •Treatment with BCG in the meantime between TUR-B and study inclusion
Investigators
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