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The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUR-B | TUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexvix | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate | Detection rate is defined as number of lesions detected or not (Detection by HAL cystoscopy compared to white light cystoscopy confirmed by histology). | At TUR-B visit, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate for risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC)-score | Risk groups are low, intermediate and high. | At TUR-B visit, up to 1 year |
| Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations |
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Inclusion Criteria:
Exclusion Criteria:
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Bladder cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caritas-Krankenhaus St. Josef, Klinik fuer Urologie | Regensburg | 93059 | Germany | |||
| Klinikverbund Südwest |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
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| At TUR-B visit, up to 1 year |
| Sindelfingen |
| 71065 |
| Germany |