NCT06844513

Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform

HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN).

Detailed description

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN). The study is divided into a patient enrolment and robot-assisted treatment phase, followed by a phase of oncological and functional follow-up. Once enrolled, patients will be randomized to undergo treatment using either the Da Vinci Xi platform (Intuitive Surgical) or the HUGO™ RAS platform (Medtronic) according to block randomization. Patients with prostate cancer (Group A), enrolled according to inclusion criteria, will be randomized to undergo RP treatment with the Da Vinci Xi platform (control group) or RP treatment with the HUGO™ RAS platform (study group). Patients with kidney cancer (Group B), enrolled according to inclusion criteria, will be randomized to undergo PN treatment with the Da Vinci Xi platform or PN treatment with the HUGO™ RAS platform. If the surgical, oncological, and functional outcomes observed following radical prostatectomy and partial nephrectomy performed with the HUGO RAS platform prove to be equivalent to those obtained with the Da Vinci Xi platform, it should lead to a progressive increase in the use of the HUGO RAS platform, resulting in a reduction in the overall costs associated with robotic urological surgery.

Conditions

• Prostate Cancer (Adenocarcinoma)
• Renal Cancer

Interventions

Type	Name	Description
PROCEDURE	Radical prostatectomy	Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform
PROCEDURE	Partial nephrectomy	partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform

Timeline

• Start date: 2025-03-31
• Primary completion: 2028-01-01
• Completion: 2033-03-01
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: Italy