Trials / Completed
CompletedNCT02560584
A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
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
- Phase 3
- Study type
- Interventional
- Enrollment
- 304 (actual)
- Sponsor
- Photocure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hexaminolevulinate hydrochloride | Instillation in bladder |
| DEVICE | KARL STORZ D-Light C PDD Flexible Videoscope System | Cystoscopy procedure |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-04-05
- Completion
- 2017-04-05
- First posted
- 2015-09-25
- Last updated
- 2018-07-02
- Results posted
- 2018-07-02
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02560584. Inclusion in this directory is not an endorsement.