Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318559
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-15
Brief Title:
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy vs no3D Intervention
Sponsor:
Fondazione del Piemonte per lOncologia
Organization:
Fondazione del Piemonte per lOncologia
Study Overview
Official Title:
RIDERS Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy vs no3D Intervention a Prospective Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
RIDERS
Brief Summary:
This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs no 3D verifying the impact of this new technology on oncological and functional outcomes after the procedure
Detailed Description:
Considering that prostate cancer lesions are not identifiable during surgery except in the case of extensive and advanced tumors the surgeon does not have a real-time perception of the location of the tumor The absence of clear spatial visualization can therefore lead to a positive surgical margin particularly in tumors in the T3 stage invasion of the prostatic capsule or seminal vesicles
Our hypothesis is that with the help of AI 3D AR during surgery positive surgical margins can be avoided or at least reduced while preserving the neurovascular bundles with a consequent improvement not only in postoperative functional outcomes continence and potency but also oncological ones less biochemical disease recovery BCR less need for salvage radiotherapy lower risk of metastasis
Our hypothesis is that with the help of AI 3D AR during surgery positive surgical margins can be avoided or at least reduced while preserving the neurovascular bundles with a consequent improvement not only in postoperative functional outcomes continence and potency but also oncological ones less biochemical disease recovery BCR less need for salvage radiotherapy lower risk of metastasis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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