Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT06318559
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).
Study:
NCT06318559
Study Brief:
Protocol Section:
NCT06318559