Ignite Creation Date:
2024-05-06 @ 7:35 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02560584
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2015-09-23
Brief Title:
A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
Sponsor:
Photocure
Organization:
Photocure
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-05
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 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
Detailed Description:
None
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