Photodynamisk Diagnostik (PDD) ved flexible cystoskopier - et randomiseret studie med fokus på recidiv
Phase 1
Active, not recruiting
- Conditions
- Patients with non muscle invasive bladder cancer in their first year after the diagnosis.MedDRA version: 18.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000436-15-DK
- Lead Sponsor
- Aarhus Universitet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 696
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method