A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
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|ClinicalTrials.gov Identifier: NCT02560584|
Recruitment Status : Completed
First Posted : September 25, 2015
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Hexaminolevulinate hydrochloride Device: KARL STORZ D-Light C PDD Flexible Videoscope System||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
This is a prospective, open, comparative, within-patient controlled Phase 3 multicenter study in patients with bladder cancer. There is a maximum of three study visits for an enrolled patient:
Visit 1: Screening visit Visit 2: Surveillance cystoscopy in white light (WL) followed by blue light (BL) Visit 3: Operating room (OR) cystoscopy in WL followed by BL for patients with suspicion of recurrence after surveillance cystoscopy.
Cystoscopy in WL followed by BL is performed in all patients after Cysview instillation. Only patients with suspicious lesions at Visit 2 continue to a second cystoscopy in WL followed by BL at Visit 3.
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 1, 2015|
|Actual Primary Completion Date :||April 5, 2017|
|Actual Study Completion Date :||April 5, 2017|
Experimental: Cysview arm
In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure)
All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours.
Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System
Drug: Hexaminolevulinate hydrochloride
Instillation in bladder
Other Name: Cysview
Device: KARL STORZ D-Light C PDD Flexible Videoscope System
- Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy [ Time Frame: At time of cystoscopy procedure ]In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured.
- Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination [ Time Frame: At time of cystoscopy procedure ]
- Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy [ Time Frame: At time of cystoscopy procedure ]In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560584
|Principal Investigator:||Mark Schoenberg, MD||Montefiore Medical Center|
|Principal Investigator:||J. Stephen Jones, MD||The Cleveland Clinic|