Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform

NCT ID: NCT06844513

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2033-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prostate cancer

Patients with prostate cancer (Group A), enrolled according to the inclusion criteria, are randomized to undergo radical prostatectomy (RP) using either the Da Vinci Xi platform (control group) or the HUGO™ RAS platform (study group).

Group Type: ACTIVE_COMPARATOR

Radical prostatectomy

Intervention Type: PROCEDURE

Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform

kidney cancer

patients with kidney cancer (Group B), enrolled according to the inclusion criteria, are randomized to undergo partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform.

Group Type: ACTIVE_COMPARATOR

Partial nephrectomy

Intervention Type: PROCEDURE

partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform

Interventions

Radical prostatectomy

Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform

Intervention Type: PROCEDURE

Partial nephrectomy

partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients with Prostate Cancer (Group A)

• Age ≥ 18 years.
• Life expectancy greater than 10 years.
• Diagnosis of prostate cancer following prostate needle biopsy.
• Clinical stage cT1-T3b, N0-1 disease.
• Positive anesthetic fitness assessment for robot-assisted radical prostatectomy.
• Provision of informed consent for the study.

Patients with Kidney Cancer (Group B)

• Age ≥ 18 years.
• Radiological diagnosis of organ-confined kidney cancer at clinical stage T1a or T1b.
• Underwent CT and/or MRI of the abdomen with contrast medium.
• Positive anesthetic fitness assessment for robot-assisted partial nephrectomy.
• Provision of informed consent for the study.

Exclusion Criteria

Patients with Prostate Cancer (Group A)

• Expression of a preference for radical treatment other than surgery (e.g., external radiotherapy).
• Metastatic prostate cancer (M1).
• Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.

Patients with Kidney Cancer (Group B)

• Indication for radical nephrectomy.
• Metastatic kidney cancer (M1).
• Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugenio Brunocilla, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Countries

Italy

Central Contacts

Eugenio Brunocilla, Prof, MD

Role: CONTACT

eugenio.brunocilla@unibo.it

+39 051 2142374

Facility Contacts

Eugenio Brunocilla

Role: primary

eugenio.brunocilla@unibo.it

+39 051 2142374

Other Identifiers

URO ROBOT 2023

Identifier Type: -

Identifier Source: org_study_id