At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 304 enrolled
Drug / intervention
Hexaminolevulinate hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Hexaminolevulinate hydrochloride and KARL STORZ D-Light C PDD Flexible Videoscope System for Bladder Cancer. Completed, enrolled 304 participants across 17 sites.
Detailed Summary
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsKARL STORZ Endoscopy-America, Inc.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionApr 2017
TodayJul 2026
First PostedSep 25, 2015
Enrollment StartOct 1, 2015
Primary CompletionApr 5, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.8 years ago
Interventions
Hexaminolevulinate hydrochloridedrug
Instillation in bladder
KARL STORZ D-Light C PDD Flexible Videoscope Systemdevice
Cystoscopy procedure