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: 19 Jun 2017

At a glance

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

    • 14 May 2017 According to a Photocure media release, the company intends to submit the data from this trial to the US FDA to seek approval of BLFC with Cysview in the surveillance setting in the US, and an expansion of the indication to include CIS.
    • 14 May 2017 Results published in the Photocure Media Release
    • 14 May 2017 According to a Photocure media release, results from this study were presented during a late-breaking plenary session at the American Urological Association (AUA) Annual Meeting 2017.
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