Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412971
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2006-12-18
Brief Title:
A Randomized Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
A Randomized Comparative Phase III 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
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 main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder TURB to standard white light TURB in patients with suspicion of non-invasive bladder cancer
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB
Detailed Description:
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder TURB to standard white light TURB in patients with suspicion of non-invasive bladder cancer
Patients will be followed 4 8 and 12 months after the initial TURB This follow-up regimen is according to standard clinical practice in Denmark
Recurrence of non-invasive bladder cancer is frequent and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB
Patients will be followed 4 8 and 12 months after the initial TURB This follow-up regimen is according to standard clinical practice in Denmark
Recurrence of non-invasive bladder cancer is frequent and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB
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