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

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2017

At a glance

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

    • 23 Aug 2017 According to a Photocure media release, the possible sNDA approval is expected in 2018.
    • 16 Aug 2017 According to a Photocure media release, the sNDA filing is a combination drug device application with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System. The sNDA also supports the approval for repeated use of BLC with Cysview and to expand the indication include detection of carcinoma in situ (CIS).
    • 16 Aug 2017 According to a Photocure media release, based on the results from this study the company has submitted a supplemental new drug application (sNDA) to the US FDA, for use of Blue Light Flexible Cystoscopy with Cysview for use during surveillance cystoscopy to detect recurrence of bladder cancer using a flexible cystoscope.
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