Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946603
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-06-28
Brief Title:
IS-002 in Prostate Cancer
Sponsor:
Intuitive Surgical
Organization:
Intuitive Surgical
Study Overview
Official Title:
Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da Vinci Surgical System With Firefly Fluorescence Imaging
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Phase 2 randomized controlled multi-center study of IS-002 in conjunction with near-infrared NIR fluorescence imaging for identification of prostate cancer during robotic-assisted radical prostatectomy RARP with extended pelvic lymph node dissection ePLND using the da Vinci XXi Surgical System with Firefly Fluorescence Imaging
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None