Study To Optimize Photodynamic Transurethral Resection of the Bladder (TUR-B) In Clinical Practice
NCT ID: NCT02012036
Last Updated: 2019-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2013-07-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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TUR-B
TUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC).
Hexvix
As this is a non-interventional study, detection of NMIBC with Hexvix is in a pre-defined group, chosen prior to and independently from the decision to enrol the subject in this study.
The detection with Hexvix should be in accordance with local Summary of Product Characteristics \[SmPC\].
Subjects will be treated in accordance with usual medical practice during their participation in this study, no additional assessment or tests will be required.
Interventions
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Hexvix
As this is a non-interventional study, detection of NMIBC with Hexvix is in a pre-defined group, chosen prior to and independently from the decision to enrol the subject in this study.
The detection with Hexvix should be in accordance with local Summary of Product Characteristics \[SmPC\].
Subjects will be treated in accordance with usual medical practice during their participation in this study, no additional assessment or tests will be required.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject able to comply with the protocol.
* Written informed consent available.
Exclusion Criteria
* Porphyria.
* Gross haematuria.
* Women of child-bearing potential.
* Repeated TURB (control TURB) as part of follow-up after previous TURB.
* Bacillus Calmette-Guerin (BCG) or Mitomycin / intravesical chemotherapy instillation therapy in the last 12 weeks or any other contraindications according to the SmPC.
* Subjects not able to give informed consent.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Caritas-Krankenhaus St. Josef, Klinik fuer Urologie
Regensburg, , Germany
Klinikverbund Südwest
Sindelfingen, , Germany
Countries
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Other Identifiers
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A-94-58150-002
Identifier Type: -
Identifier Source: org_study_id
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