Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446648
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Impact of Intraoperative ICG on Functional Outc in RARP
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a pilot 3 phases open-label feasibility study with the 3rd phase consisting of randomized 2-arm intervention trial to assess the systematic use of indocyanine green ICG in subjects with prostate adenocarcinoma during robot-assisted radical prostatectomy and its impact on sexual function outcomes at 12 months postoperatively
Detailed Description:
The first phase of this study will involve performing 50 cases of nerve-sparing RARP on patients who are good candidates for nerve sparing During these procedures we will record the location and size of arteries encountered to create a detailed 3D map of the surgical arterial vasculature
In the second phase we will recruit another 50 patients These patients will receive an IV injection of ICG before encountering the arteries to visualize them prior to resection This phase will determine the optimal dosage and timing for the IV ICG injection
The third phase will utilize the dosage and timing defined in the second phase This phase will be a randomized trial involving 300 patients
In the second phase we will recruit another 50 patients These patients will receive an IV injection of ICG before encountering the arteries to visualize them prior to resection This phase will determine the optimal dosage and timing for the IV ICG injection
The third phase will utilize the dosage and timing defined in the second phase This phase will be a randomized trial involving 300 patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCI 23-137 | OTHER | UCI CFCCC | None |