Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01166230
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2010-07-19
Brief Title:
Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix CysviewFluorescence CystoscopyTURB
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
An Open Non-interventional Retrospective Comparative Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB30504 to Assess Longer-term Recurrence Rates in Patients After Hexvix CysviewFluorescence CystoscopyTransurethral Resection of the Bladder TURB or White Light CystoscopyTURB
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix Cysview fluorescence cystoscopyTURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopyTURB
Detailed Description:
A previously completed pivotal clinical study PC B30504 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix Cysview and white light cystoscopy and transurethral resection TURB of the bladder compared to patients who underwent white light cystoscopy and TURB alone
The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix Cysview fluorescence cystoscopyTURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopyTURB
No safety data was collected
The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix Cysview fluorescence cystoscopyTURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopyTURB
No safety data was collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None