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A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer

Trial Profile

A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Feb 2023

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At a glance

  • Drugs Hexyl aminolevulinate (Primary)
  • Indications Bladder cancer
  • Focus Diagnostic use; Registrational
  • Acronyms BRAVO
  • Sponsors PhotoCure
  • Most Recent Events

    • 19 Feb 2023 According to Photocure media release, the company has announced the presentation of clinical trial data from this study at the ASCO Genitourinary Cancers Symposium (ASCO GU) which was held in 16th-18th February.
    • 06 Jul 2018 Results (n=304) published in the BJU International.
    • 16 Feb 2018 According to a Photocure media release, based on the results from this study, the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for use of Blue Light Cystoscopy (BLC(TM)) with Cysview for use during surveillance cystoscopy to detect recurrence of bladder cancer using a flexible cystoscope.
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